job description biostatistician clinical research

Clinical Trials and Biostatistics

Clinical trials and biostatistics research and services are carried out by a talented, diverse, and specialized collaborative team. This includes not only physician and scientist faculty members but also a wide range of allied health and technical staff. Career opportunities with the Division of Clinical Trials and Biostatistics are frequently available at Mayo Clinic's campuses in Florida, Arizona and Minnesota. In addition to full-time positions, the division has summer internships available.

Faculty careers

Openings for clinician-researchers and faculty-level scientists can found by visiting Mayo Clinic's careers page .

Allied health careers

The Division of Clinical Trials and Biostatistics has allied health career opportunities for candidates with bachelor's, master's and doctoral degrees.

The two primary allied health job categories in the Division of Clinical Trials and Biostatistics are:

Statistical programmer. Statistical programmers should be experienced in computer programming and the use of statistical software such as SAS and R for data management and performing analyses. Proven written and oral communication skills also are essential.

Candidates must have a Bachelor of Science degree in statistics or another quantitative science with experience and coursework in applied statistics. At least one object-oriented programming class is desired.

Biostatistician. Biostatisticians at Mayo Clinic function as statistical consultants and project coordinators by applying statistical, computational and scientific expertise to the design, implementation, analysis, interpretation and reporting of research, clinical and administrative studies.

Biostatistician positions require a graduate degree in statistics or biostatistics, experience with computer programming, familiarity with statistical software such as SAS and R interpretable machine learning (IML), and excellent written and oral communication skills. Prior consulting and project management experience is preferred.

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Biostatistics Careers and Job Outlook

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Data is transforming health care, just as it’s transformed nearly every other field of endeavor. However, data is a resource whose value is realized only after it’s been processed and analyzed. Biostatisticians play key roles in unlocking the potential of data to revolutionize the health care industry and enhance the health and well-being of individuals and communities.

Biostatistics applies statistical theory and mathematical principles to biological and health data to help identify the causes of disease, devise effective treatments and implement preventive measures. The growing importance of biostatistics is evident in the wide variety of biostatistics careers available to people who possess the skills and experience to convert the ever-expanding quantity of medical and health data into insights that support the decisions that policymakers and health care professionals make.

These are just three examples of the roles biostatistics can play in improving health systems and individual outcomes:

• The Helmholtz Center for Infection Research applies biostatistics techniques to forecast the potential of health systems to be overwhelmed by COVID-19 patients .
• Biostatistics measured the effectiveness of public health interventions in Mozambique to address sanitary conditions and improve patient outcomes.
• Statistical models identified characteristics associated with short- and long-term survival rates for people diagnosed with colorectal cancer.

What Is Biostatistics?

The short answer to the question, “What is biostatistics?” is that it’s the field of medicine focused on the application of statistical methods and principles to the study of biology. The terms “biostatistics” and “biometry” are often used interchangeably , although biometry’s broader definition encompasses all the biological sciences, while biostatistics is typically limited to medical applications.

The International Biometric Society defines biometry as the science concerned with the development and use of statistical and mathematical methods to solve problems in biology via data analytics. Biostatistics encompasses such health-related fields as genetics, genomics, neuroscience, environmental health and pharmaceuticals. However, the work of biostatisticians touches every aspect of medicine and health care: from pharmaceutical research seeking new treatments to clinical research measuring the effectiveness of cutting-edge therapies for combating cancer, heart disease and other maladies.

Converting Medical and Health Data into Insights

At its most fundamental level, biostatistics is the field that converts data related to disease, medicine and public health into insights that help health care professionals and health policymakers address the challenges related to the health of individuals and communities. However, for the data to be useful and trustworthy, it must be validated :

• Complete: The degree to which all required data is known.
• Clean: Data errors are corrected or removed, irrelevant data is excluded and duplicate data is excised.
• Contextualized : Data values are confirmed to be appropriate for their context.
• Normalized : Data looks and reads the same across all records in the data set.

Primary sources of data for biostatistics applications include electronic medical record (EMR) and electronic health record (EHR) systems. Accessing useful data for creating statistical models and using other analytics tools requires open systems and consistent data formats across health care organizations. New cloud-based data analytics platforms hold promise for overcoming obstacles related to file formats, timely data sharing and securing patients’ private information.

How Biostatistics Contributes to Medical Research and Treatment

Biostatisticians contribute to researchers developing more effective treatments for cancer and infectious diseases, as well as those working in environmental health and behavioral sciences. Among the ways that biostatistics supports cutting-edge medical research are:

• Clinical trials: Help design studies, optimize sample sizes, choose data collection methods and clean data.
• Public health programs: Assist health officials in government, nonprofit organizations and hospitals in understanding the significance of public health research.
• Epidemiological studies: Contribute to research by public health professionals into the factors that influence the causes, behavior and distribution of disease outbreaks, such as COVID-19.
• Meta-analysis and evidence-based medicine: Perform systematic reviews of medical research on specific topics to integrate results and identify potential outcomes that can be applied to develop evidence-based health care.
• Genome sequencing: Cut through the complexity of the massive amounts of data generated by genome sequencing to distinguish genetic traits and variants that may cause disease.

How Advanced Statistical Methods Benefit Medicine and Health Sciences

Generating valid and reliable results requires choosing the correct statistical methods and approaches for the unique characteristics of each research study. Other researchers must also be able to reproduce the research results. Among the techniques that biostatisticians employ are:

• Multiple testing problem (multiplicity) : Biostatisticians must account for the damage that an error in the data has caused that could result in a false positive being inflated when a set of hypotheses is tested simultaneously within a single study.
• Bayesian analysis : Bayesian analysis is a statistical technique that uses probability statements to answer questions about unknown parameters.
• Model averaging : In model averaging, several models run simultaneously, either to make predictions or infer parameters.
• Causal inferences : Causal inference is a form of inductive reasoning that concludes that some entity is or isn’t likely to be the cause of something else.
• Estimation in disease state changes : Morbidity measures the incidence (number of persons who become ill) and prevalence (number who are ill at a given time) of a disease, injury or disability. Estimation is used to calculate incidence proportion (risk) for new diseases or injuries.

What Does a Biostatistician Do?

The primary role of biostatisticians is to apply mathematical and statistical techniques to determine the causes of diseases, injuries and other health issues. More specifically, what a biostatistician does is work as part of a team of researchers and health care providers to discover more effective approaches to the treatment and prevention of common illnesses, including the following:

• Devising more effective solutions to health problems
• Developing faster and more affordable treatment options
• Discovering new ways to apply data analytics tools to help solve problems related to individual health care and public health

Duties and Responsibilities of Biostatisticians

The roles of biostatisticians frequently overlap with those of medical informaticians, bioinformaticians and epidemiologists. The four broad categories of biostatistician tasks and responsibilities are clinical trials, interventional studies, statistical genetics, and systematic reviews and meta-analyses.

• Biostatisticians participate in the design of clinical trials as well as in the analysis of the data that they generate. This includes determining the protocol, preparing case report forms, and writing interim and final reports.
• For observational studies , biostatisticians apply mathematical equations to explain the relationships between variables, whether via multiple measures of the same subject over time or studies of multiple patients interacting with different departments in a health care facility.
• When working on projects related to statistical genetics , biostatisticians integrate findings from mathematics, statistics, genetics, epidemiology and bioinformatics. This requires a background that encompasses a range of disciplines and familiarity with various modeling techniques.
• Determining the level of evidence present in medical research studies requires systematic reviews and meta-analysis that biostatisticians conduct to identify the value of the research results to other researchers and health care professionals.

The education and training required to become a biostatistician begins with earning a master’s degree in biostatistics or public health with concentrations in biostatistics and epidemiology. The most common skills of biostatisticians include mathematics and statistical analysis, problem-solving, critical thinking, communication and teamwork. Among the technical skills that may be required to qualify for a position as a biostatistician are:

• SAS , R and other statistical programming languages
• Relational and nonrelational databases
• Ruby, Python and other general programming languages

Biostatisticians rely on various tools in their work, which includes designing statistical studies and applying advanced analysis techniques to extract intelligence from massive health care datasets. Here are 10 popular statistical tools that biostatisticians use, according to Kolabtree: Stata, R, GraphPad Prism, SAS, IBM SPSS, MATLAB, JMP, Minitab, Statista and Microsoft Excel.

Typical Workday of a Biostatistician

Biostatisticians usually work a standard 40-hour week, although they may work overtime to meet deadlines for specific projects. While biostatisticians do much of their work on computers, their job requires interacting with team members, writing reports, and other communication and interpersonal duties. The profession allows people to contribute to improving the health of people in their communities without participating directly in their treatment.

• Typical data sources for medical and health statistics include surveys, administrative and medical records, claims data, vital statistics from government agencies, surveillance, disease registries and peer-reviewed literature.
• Among the statistical analysis tools that biostatisticians use are the IBM Statistical Package for the Social Sciences (SPSS), MATLAB , GraphPad Prism and Microsoft Excel.
• Collaboration with other researchers , health care professionals and public officials is a vital part of the work that biostatisticians do and the focus of much of their training.

Common Biostatistician Projects and Work Environments

Biostatisticians are employed by private companies, research foundations, educational institutions and government agencies. They spend much of their time working on computers in offices and research facilities as part of a team of researchers, scientists and other professionals in public health and health-related fields. In addition to projects involving the use of SAS, R and other statistics and data analytics tools, biostatisticians participate in these research tasks :

• Study design and protocol development
• Quantitative and qualitative research projects
• Data analysis and interpretation for clinical trials
• Data administration and management
• Public health modeling of disease outbreaks
• Survival analysis for new drugs and treatment approaches
• Institutional review boards (IRBs) to vet the ethics of research procedures
• Research on the effectiveness of cancer treatments

Resources on the Roles and Responsibilities of Biostatisticians

• Pubrica Academy, Role of Biostatistics and Responsibilities of Biostatisticians in Clinical Medical Research — A description of biostatistics applications and the contributions of biostatisticians to medical research projects.
• CROS NT, How Well Do You Understand the Role of Biostatisticians in Medical Research? — An explanation of biostatisticians’ work for nonstatisticians who are members of clinical research teams.

Is Biostatistics a Good Career?

The American Statistical Association (ASA) predicted that 2021 would be “ a year of opportunity for statisticians ” because of growing demand for advanced data analytics skills in pharmaceutical manufacturing, government and other large sectors of the economy.

• Statistician is rated the sixth best career in S. News & World Report ’s listing of the 100 best jobs of 2021. It’s also rated the fifth best science, technology, engineering and math (STEM) job and the second best business job.
• The U.S. Bureau of Labor Statistics (BLS) identifies statistician as the fourth fastest growing career on its list of the 20 fastest growing occupations between 2019 and 2029; the number of jobs is forecast to increase by 35% in that period.
• BioSpace estimates that employment opportunities for biostatisticians will increase by 31% in the U.S. between 2019 and 2028.

Career Options for Biostatisticians

Entry-level positions in biostatistics are available in all areas of medicine and scientific research, including medical assistant, research fellow, software engineer, laboratory technician and instructor. The employment site Zippia describes the 10 best jobs for people entering the field of biostatistics:

• Data analyst
• Biostatistician
• Data scientist
• Statistician
• Software engineer
• Research analyst
• Research internship
• Bioinformatics analyst
• Bioinformatics scientist

Careers in biostatistics involve working in one or more of four areas: clinical trials, public health programs, genome sequencing research and epidemiological studies.

Participating in Clinical Trials

Clinical trials evaluate the effectiveness of medical, surgical and behavioral interventions on patients recruited specifically for the studies. The trials also help determine whether specific treatments have more or less harmful side effects than existing approaches. Some trials attempt to identify diseases before symptoms arise or to prevent diseases entirely; they may also study the role of caregivers and support groups in treating and preventing illnesses.

Contributing to Public Health Programs

The goal of public health programs is to ensure conditions in which people can be healthy. Biostatistics plays a pivotal role in these programs by addressing all three core public health functions :

• Assessment identifies problems that threaten a population’s health and the extent and seriousness of that threat.
• Policy development prioritizes the problems, determines possible intervention and prevention measures, implements policies and regulations to address the problems, and predicts the effects of the policies on the at-risk population.
• Assurance puts in place the services necessary to achieve the goals of the policies and regulations and monitors the community’s compliance with the policies.

Conducting Genome Sequencing Research

Biostatistics is central to the work that medical researchers do to create The Cancer Genome Atlas (TCGA) and the International Cancer Genome Consortium (ICGC) to support cancer genomics:

• To produce somatic variant call sets from exome (TCGA)
• To create whole genome-level models (ICGC)

The two programs rely on “ scientific crowdsourcing ” to aggregate whole genome sequencing data from 2,658 cancers representing 38 tumor types. The result was 746 samples that serve as benchmarks for comparing exome and genome somatic variant detection techniques.

Performing Epidemiological Studies

A timely example of biostatistics applied to determine the causes and effects of diseases is the work that medical researchers have done to measure the effectiveness of vaccines that prevent COVID-19 . Statistical techniques were used to estimate the effects of the vaccines in case-control and test-negative frameworks while accounting for bias in the results.

The research findings serve as guideposts for public health agencies and health care providers investigating the most effective strategies for measuring the impact and effect of COVID-19 vaccinations on specific populations, including asymptomatic individuals.

Industries in Which Biostatisticians Are Employed

Biostatisticians are qualified to work in any setting that relies on calculating risk and predicting outcomes .

Most careers in biostatistics focus on one of four specific fields of medicine : epidemiology, public health, pharmaceuticals and genetics:

• Among the biostatistics specialties within epidemiology are environmental, genetic, social and nutritional statisticians. Typical activities include determining the rates of infectious and chronic diseases and tracking outbreaks of disease.
• The goals of public health statisticians are to prevent disease and promote long, healthy lives. They work on ways to improve sanitation, prevent infectious diseases, and educate the public on health and hygiene topics.
• Pharmacology statisticians support drug discovery activities, as well as drug development, approval and marketing. They participate in clinical trials, preclinical research and other aspects of drug development.
• Biostatistics is applied in genetics research to automate the process of identifying sequences that may indicate abnormalities causing birth defects and other health problems.

Biostatisticians work in offices, laboratories and in the field conducting a range of tasks, from designing research studies to analyzing and reporting on their results. In addition to technical and statistical skills, Indeed reports that biostatisticians require several personal and professional skills: written and oral communication, problem-solving, critical thinking, ability to work autonomously and adaptability.

Importance of Keeping Current on Biostatistics Tools and Techniques

Machine learning and other areas of artificial intelligence (AI) will continue to impact the way medical and health data is analyzed. The techniques will also facilitate gathering and processing the large quantities of data that will be generated in the future. Increased automation will enhance the use of seven different types of statistical analysis .

• Descriptive statistical analysis is a straightforward summary of the data and its characteristics, with no attempt to infer anything from the analysis.
• Inferential statistical analysis derives inferences from the data to suggest from the sample data what the population at large may think or how they may act, for example.
• Predictive statistical analysis applies statistics and mathematical models to current and past data to predict what will occur or how something will perform.
• Prescriptive statistical analysis goes beyond prediction to recommend specific actions based on its analysis of current and past data. The actions suggested may be in the short or long term.
• Exploratory data analysis performs a cursory analysis of the data prior to the full-scale investigation as a way to check assumptions, identify potential errors and spot patterns.
• Causal analysis attempts to explain why health-threatening events, such as COVID-19, occur and spread through a population.
• Mechanistic analysis examines the precise biological mechanisms that caused actions, as well as the various responses to those actions, as a way to discover how to reduce adverse reactions.

Resources on Careers in Biostatistics

• American Statistical Association, Career Resources — The professional association provides links to salary information, fellowships and grants, funding, ethics, and job opportunities.
• The Balance Careers, “How to Become a Biostatistician” — Among the topics covered are typical work hours, qualifications and related careers.

Biostatistics vs. Bioinformatics

While much overlap exists between biostatistics vs. bioinformatics, the two fields are distinct primarily in the scope of the projects they’re applied to.

• Bioinformatics uses computational technology to organize and analyze the huge data sets that studies in molecular biology are generating, including gene sequencing; gene expression studies; and pharmacogenomics , which studies how genes impact the way a person responds to drugs.
• Biostatistics has a much broader scope, covering the use of statistics and mathematical modeling to analyze and evaluate research relating to public health, medicine, biology and environmental health.

Biostatistics vs. Bioinformatics: Education and Skills

Most biostatisticians earn a master’s degree in biostatistics or public health with concentrations in biostatistics and epidemiology. The educational background required to qualify for positions in biostatistics is weighted heavily toward statistics, mathematics, programming, life sciences and physical sciences. The profession also calls for strong communication and interpersonal skills because much of the work entails collaborating with team members from diverse backgrounds.

For careers in bioinformatics, the educational requirements include a strong background in molecular biology and genetics as well as several bioscience specialties within those categories:

• Cell biology
• Comparative genomics
• Genetic mutations
• Chromosomes and gene expressions
• Molecular cloning
• Immunogenetics
• Gene mapping
• Gene sequencing
• Protein synthesis
• DNA and RNA

Bioinformaticists must be familiar with many different software tools , including the Genome Analysis Toolkit (GATK); the Blast and Bowtie sequence alignment systems; and Partek and other programs for sequencing, microarray and data analysis. Bioinformaticists and biostatisticians both rely on statistical analysis tools, such as SAS and IBM SPSS, as well as programming and machine learning skills.

Biostatistics vs. Bioinformatics: Roles and Responsibilities

Bioinformatics focuses on the collection and analysis of genetic codes and other complex biological data. Conversely, biostatistics emphasizes the design, implementation, analysis and interpretation of studies designed to improve medical treatments and public health in general.

• Bioinformaticists typically work on large databases of omics data: a subset of biotechnology that studies the functions and characteristics of specific biological processes. These include genomics for genes, proteomics for proteins and metabolomics for metabolic functions. The Human Genome Project is an example of the size and scope of such projects.
• Biostatisticians generally are involved in a broader range of topics related to medical and clinical research. They contribute to the design of studies, the protocols to be followed, and monitoring of ongoing research to ensure safety and efficacy.

Resources on Biostatistics vs. Bioinformatics

• Yoh, “Bioinformatics vs. Biostatistics: What’s the Difference?” — An explanation of the close links between the two fields as well as their primary distinctions in terms of broad vs. narrow focus of study.
• National Cancer Institute Center for Cancer Research, Bioinformatics Training and Education Program: Resources — Resources including support programs and collaborations, bioinformatics software resources, and sequencing facilities.

Biostatistics Salary

The BLS estimates that the median annual salary for statisticians working in research and development in the physical, engineering and life sciences was $102,370 as of May 2020. For biostatistics salaries in particular, the BLS reports that statisticians in insurance and related fields had a median annual salary of $88,450, and those working in health care and social assistance earned a median annual salary of $79,440.

The salary survey site PayScale reports that annual salaries for biostatisticians range from about $67,000 for people with one year or less of experience to approximately $129,000 for those with 20 years or more of experience. The median annual salary for all biostatisticians was about $77,000 as of July 2021, according to PayScale. For senior biostatisticians , the median annual salary was around $110,000.

Skills That Can Boost a Biostatistician’s Salary

According to figures that PayScale compiled, specific skills can affect biostatisticians’ salaries:

• Machine learning: 60% higher than the average salary
• Bioinformatics: 27% higher
• Research analysis: 8% higher
• Clinical research: 3% higher

Median annual salaries for biostatisticians who possess certain skills include the following (all figures as of July 2021):

• Clinical research: about $79,000
• Statistical analysis: about $79,000
• SAS: about $77,000
• Data analysis: about $76,000

With experience, biostatistician salaries increase at a steady rate:

• With 5 to 9 years of experience: $88,000
• With 10 to 19 years of experience: $98,000
• With 20 or more years of experience: $129,000

Biostatistics Job Outlook

The results of the ASA’s  2020 Work and Salary survey indicated that statisticians were happy with their chosen occupation:

• 55% of statisticians responding to the survey reported being very satisfied with their primary job, and an additional 36% were somewhat satisfied.
• 65% reported being very satisfied with their job security, 41% were very satisfied with their pay and 31% were very satisfied with their opportunities for advancement.
• The two work attributes that the survey respondents rated very important were doing interesting and enjoyable work (83%) and doing work that makes a positive contribution (73%).

This high level of job satisfaction is mirrored in the BLS’s job outlook for the profession: While growth for all statisticians is estimated to be 35% between 2019 and 2029, the health care industry’s and public policymakers’ growing reliance on data analytics will drive much of that increase, according to the BLS.

Data’s Growing Importance to Healthy Populations

The ever-increasing amount of data being collected about health, disease and genetics has the potential to lead to breakthroughs in public health and the health of individuals. This increases the importance of the role of biostatisticians in converting medical and health data into knowledge and intelligence that health care professionals and public health policy decision-makers can use.

The World Bank’s World Development Report 2021: Data for Better Lives identifies three pathways for the use of data to promote the health and well-being of communities and populations.

• The top pathway uses data to monitor the effects of government policies and individuals’ access to health care and other public services.
• The middle pathway uses data to support evidence-based policymaking and to improve the delivery of public services.
• The bottom pathway uses data to drive growth in the private sector’s provision of services.

Biostatistics plays a key role in enhancing the quality and accessibility of health care and promoting disease prevention through scientific and clinical research and the development of consistent and effective public health policies. Achieving these goals will require innovative approaches to repurpose and combine data sources in ways that are open, transparent and able to meet the needs of all stakeholders in public and private health care.

Biostatisticians as Key Contributors to a Healthier Future

The many challenges to public health brought to light as the world joined together to combat the COVID-19 pandemic also point toward solutions that new technologies have driven that can transform data into actionable insight. Making these insights available to decision-makers in health care and public policy depends on the work of biostatisticians. The result of their work is improved patient outcomes; prospering communities; and healthier, happier, more productive individuals. Individuals who are interested in a biostatistician career should consider pursuing a master’s degree in biostatistics or public health to develop the knowledge and skills to excel in the field.

Infographic Sources:

Indeed, “Learn About Being a Biostatistician” Kolabtree, “Top 10 Statistical Tools Used in Medical Research”

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What Is a Biostatistician? 2024 Career Guide

Ever wondered what a biostatistician does? Here’s a guide to everything you need to know to get started in this career.

Biostatisticians are data collectors and analysts who focus on biology for fields such as medicine, agriculture, and public health. Working at the intersection of health and data science , they are the wizards who produce and verify statistics like: “The risk of hospitalization from COVID-19 after vaccination is about 5 in 100,000.” [ 1 ].

Amid the ongoing pandemic, health care occupations are projected to grow 13 percent from 2021 to 2031, and biostatisticians can expect an even higher growth rate of 31 percent [ 2 , 3 ]. 

Biostatisticians do important work. What makes them unique are the complexities of the problems they’re solving, such as COVID-19. There is an urgency to conduct rigorous analyses in a timely manner in order to save more lives [ 4 ]. While most biostatistician jobs require a bachelor’s degree , many look for a master’s degree or higher.

Love working with health data and think it could be for you? Here’s a complete guide to becoming a biostatistician.

What is a biostatistician?

Biostatisticians collect and analyze data for biology and public health purposes using math and statistics. Biostatisticians are critical to advancing groundbreaking research, from medicine to agriculture to public health .

If you’re a data-minded individual interested in a career in medicine or health, but do not want to become a clinical doctor, nurse, or specialist, then this could be a good choice for you.

As a highly trained and educated biostatistician, you would analyze data and determine factors that impact the health and overall well-being of humans, animals, and ecology. Using this information, you and a team of researchers would deliver statistics, predictions, and studies on diseases and other health risks. They gather data at every stage of an experiment or clinical trial, to ensure thorough results from a big-picture perspective.

Where does a biostatistician work? 

Biostatisticians can work in a variety of settings on different types of research studies. 

Besides clinical settings, you can also choose to work in government or nonprofit organizations, in academia, in technology, or in a corporation. Biostatisticians sometimes work for pharmaceutical companies during their clinical studies to determine whether a drug is effective. They might do the same for a medical device company. They may work for a public health-focused non-profit to evaluate programs that inform policy making. In government-related roles, they help shape public health and education policies. 

Biostatistician salary and job outlook

Biostatisticians can expect to make an above-average salary. According to the US Bureau of Labor Statistics, mathematicians and statisticians earn a median annual salary of $96,280 [ 3 ]. As mentioned earlier, they can expect 31 percent job growth from now until 2031 [ 3 ]. Indeed lists an even higher average salary of $ 126,004 [ 5 ]. 

Read more: Biostatistician Salary: Your 2023 Guide

Biostatistician tasks and responsibilities

Biostatisticians typically work on a team of scientists and researchers to perform analyses, develop plans, and interpret results. 

Some job tasks and responsibilities of a biostatistician include:

Develop methodologies for collecting data

Designing studies and clinical trials to solve a specific problem or question

Collect and analyze large data sets

Interpret results and disseminate findings with papers and presentations

Prepare and write up reports that advise public health, education, or environmental policy

How to become a biostatistician 

Biostatisticians tend to be highly educated and trained in their fields, meaning that a master’s degree in statistics or public health is often required or recommended. Employers like to see that job candidates have experience with complex statistical analysis.

1. Earn a bachelor’s degree.

It is wise to consider a bachelor’s degree if you aspire to become a biostatistician. Most jobs require a master’s degree, and still, others will require a doctorate. Biostatisticians work with data to produce insights that can affect entire populations, so they must be experts at data analysis. 

If you’re considering the path to becoming a biostatistician, a bachelor’s degree in a quantitative major such as mathematics or statistics will set you up for success. However, don’t fret if you’ve already earned a bachelor’s degree in an unrelated field such as humanities or social sciences. A master’s in mathematics, statistics, or another data-related field, plus a strong foundation of programming and data software management skills can help you land a junior-level position as a biostatistician.

2. Gain the skills needed.

Both technical and workplace skills are needed for a role as a biostatistician. The specific skills and experience required may vary depending on the type of organization you aim to work for, so make sure to take a look at real job descriptions to understand what you’ll need to learn.

Technical skills:

Programming languages such as R , Python , C or C++, Javascript , MATLAB, and SQL

Ability to manage and clean data using data analysis software SAS

Strong knowledge of statistical theory, including longitudinal and complex data analysis  

Expert experience in a specific area, such as epidemiology or public health

Workplace skills:

Ability to multitask or contribute to multiple projects simultaneously

Excellent communication and collaboration skills

Strong, academic-level writing skills

Biostatisticians are typically inquisitive and intellectual individuals who like to investigate a problem from beginning to end. They are logical, using methodical ways of collecting and analyzing data to inform public health decisions.

3. Go for a master’s degree.

If you’re serious about becoming a biostatistician, you might be interested in pursuing a master’s degree in biostatistics, statistics, mathematics, or public health (with a focus on data and statistics). Approximately 58 percent of biostatisticians have a master’s degree, according to O*Net Online [ 6 ].

These days, with bachelor’s degrees being more ubiquitous, having a master’s degree for this type of specialized, technical job can help you stand out from the rest of the applicants. Some jobs even require a master’s degree or higher.

Biostatistics in Public Health with Coursera

If you’re looking to further your skills in biostatistics, look no further than the Biostatistics in Public Health Specialization from the best school for public health, Johns Hopkins University [ 7 ].

This specialization is intended for public health and health care professionals, researchers, data analysts, and social workers who need a primer in the concepts of biostatistics. After taking this course, which requires four months or less, you’ll be prepared to participate as part of a research team.

Article sources

Healthline. “ What Is Your Actual Risk of Getting COVID-19 If You’re Vaccinated? , https://www.healthline.com/health-news/what-is-your-actual-risk-of-getting-covid-19-if-youre-vaccinated.” Accessed December 19, 2022.

US Bureau of Labor Statistics. “ Healthcare Occupations , https://www.bls.gov/ooh/healthcare/home.htm.” Accessed December 19, 2022.

US Bureau of Labor Statistics. “ Mathematicians and Statisticians , https://www.bls.gov/ooh/math/mathematicians-and-statisticians.htm.” Accessed December 19, 2022.

Fred Hutch. “ Biostatisticians draft blueprints for COVID-19 vax trials , https://www.fredhutch.org/en/news/center-news/2021/02/biostatistician-covid-19-trials.html.” Accessed December 19, 2022.

Indeed. “ Biostatistician salary in United States , https://www.indeed.com/career/biostatistician/salaries.” Accessed December 19, 2022.

O*Net Online. “ Biostatisticians , https://www.onetonline.org/link/summary/15-2041.01#Education.” Accessed December 19, 2022.

US News. “ Best Public Health Schools , https://www.usnews.com/best-graduate-schools/top-health-schools/public-health-rankings.” Accessed December 19, 2022.

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Job Description

Research Biostatistician job description

Example research biostatistician requirements on a job description.

• Master's degree in Biostatistics or related field
• Proficiency in statistical programming languages such as SAS, R, and Python
• Experience with statistical analysis of clinical trial data
• Strong knowledge of statistical methodologies and techniques
• Familiarity with FDA regulations and guidelines for clinical trials
• Strong analytical and problem-solving abilities
• Excellent communication and interpersonal skills
• Ability to work collaboratively in a team environment
• Attention to detail and accuracy
• Ability to work independently and manage multiple projects simultaneously

Research Biostatistician job description example 1

Rehabilitation institute of michigan research biostatistician job description, research biostatistician job description example 2, kaiser permanente research biostatistician job description, research biostatistician job description example 3, midwestern university research biostatistician job description, resources for employers posting research biostatistician jobs.

Research Biostatistician job description FAQs

What are the most common skills on a job description for a research biostatistician, what does a research biostatistician do.

Updated March 14, 2024

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Related Job Descriptions

• Analytical Statistician Description
• Applied Statistician Description
• Principal Biostatistician Description
• Research Associate Description
• Research Consultant Description
• Research Fellow Description
• Research Project Coordinator Description
• Senior Statistician Description
• Statistician Description

Research Biostatistician Related Hirings

• Hiring An Analytical Statistician
• Hiring An Applied Statistician
• Hiring A Principal Biostatistician
• Hiring A Research Associate
• Hiring A Research Consultant
• Hiring A Research Fellow
• Hiring A Research Project Coordinator
• Hiring A Senior Statistician
• Hiring A Statistician

Research Biostatistician Related Jobs

• Analytical Statistician
• Applied Statistician
• Biometrician
• Mathematical Statistician
• Principal Biostatistician
• Research Associate
• Research Consultant
• Research Fellow
• Research Project Coordinator
• Senior Statistician
• Statistical Consultant
• Statistician
• Survey Statistician

What Similar Roles Do

• Analytical Statistician Responsibilities
• Applied Statistician Responsibilities
• Biometrician Responsibilities
• Mathematical Statistician Responsibilities
• Principal Biostatistician Responsibilities
• Research Associate Responsibilities
• Research Consultant Responsibilities
• Research Fellow Responsibilities
• Research Project Coordinator Responsibilities
• Senior Statistician Responsibilities
• Statistical Consultant Responsibilities
• Statistician Responsibilities
• Survey Statistician Responsibilities
• Zippia Careers
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• Research Biostatistician
• Research Biostatistician Job Description

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Position Classification Description

This is a description of a Staff Position Classification. It is not an announcement of a position opening. To view descriptions of current openings, please go to UNMJobs and Search Postings to view positions that are currently accepting applications.

The following statements are intended to describe, in broad terms, the general functions and responsibility levels characteristic of positions assigned to this classification. They should not be viewed as an exhaustive list of the specific duties and prerequisites applicable to individual positions that have been so classified.

Serves as a leading subject matter expert in statistical guidance and support to researchers, scientists, faculty, research teams, and managers engaged in research studies within the health sciences. Consults with works with investigators to formalize analysis plans and reporting specifications and provides high complexity statistical support and clinical trial statistical analyses and sample size justification assessments. Leads the design, development, and reporting of research studies and clinical trials. Represents Biostatistics on clinical and pre-clinical project teams as required, and provides leadership to staff. Develops responses to a broad range of complex statistical issues arising in a variety of clinical and health science research settings.

Duties and Responsibilities

• Creates analysis plans and study design of clinical trials, prospective cohort studies and observational studies including sample size/power calculations and missing data.
• Leads the design, analysis, implementation, and report findings on targeted statistical research studies; provides consultation to investigators and researchers on experimental design and statistical research approaches, requirements, and scientific standards to advance medical knowledge and improve research in public health.
• Consults with investigators to formalize analysis plans and reporting specifications; advises on choice of statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.
• Assists with development of new and/or resubmission of continuing contract or grant proposals, budgets, and reports.
• Supervises assigned personnel which typically include recommendations for hiring, firing, performance evaluation, training, work allocation, and problem resolution.
• Oversees or develops enhancements to statistical software by programming new techniques; maintains knowledge of current and emerging trends in statistical analysis methodology.
• Uses a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret research data to derive useful information for research data; advises and assists in the development of inferences and conclusions, as appropriate.
• Develops the responses to statistical issues arising in regulatory, quality and compliance, clinical or other legal settings; prepares clinical trial documents and reports, protocols, investigator brochures, scientific abstracts, peer-reviewed manuscripts, and responses to requests from regulatory agencies, local Institutional Review Board, and other health authorities.
• Builds and sustains collaborative relationships with individuals in different disciplines and serves as subject-matter expert for research teams, internal and external committees, other constituencies, statistical consultants and collaborators.
• Performs miscellaneous job-related duties as assigned.

Minimum Job Requirements

• Master's degree; at least 7 years of experience directly related to the duties and responsibilities specified.
• Completed degree(s) from an accredited institution that are above the minimum education requirement may be substituted for experience on a year for year basis.

Knowledge, Skills and Abilities Required

• Ability to utilize advanced analytical techniques and programs to develop scientific models.
• Ability to supervise and train employees, communicate effectively, organize, prioritize and schedule work assignments, contributing to a collaborative work environment.
• Ability to develop and produce grants and other proposals.
• Knowledge of scientific approach and methodologies.
• Knowledge and understanding of the principles, concepts, methods, and standards of statistical research.
• Ability to apply a range of advanced statistical techniques in support of scientific research studies and/or experiments.
• Ability to process computer data and to format and generate reports.
• Ability to consult with scientific investigators, interpret research requirements, and determine statistical analysis strategies.
• Ability to plan, create, program and manage complex statistical computer databases.
• Knowledge of current and emerging trends in advanced statistical analysis for scientific application.
• Knowledge of SAS programming and/or other statistical software.
• Knowledge of scientific reporting and manuscript preparation requirements and standards.
• Ability to work in a team environment to design, analyze, and report on research projects.
• Strong analytical communication, critical thinking and problem solving skills.
• Ability to provide technical guidance and leadership to professional personnel in area of expertise.
• Excellent time management skills and ability to prioritize projects.
• In-depth knowledge and understanding of probability and medical statistics theory.
• Knowledge of data management principles and regulatory requirements for clinical trials and medical research.

Distinguishing Characteristics

Conditions of employment.

• Employees who provide services or work in patient care or clinical areas are required to be in compliance with the University's influenza vaccination requirement.

Working Conditions and Physical Effort

• No or very limited physical effort required.
• No or very limited exposure to physical risk.
• Work is normally performed in a typical interior/office work environment.

The University of New Mexico provides all training required by OSHA to ensure employee safety.

Revised Date : 09/16/2022

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Biostatistician Senior Job Description

Biostatistician senior duties & responsibilities.

To write an effective biostatistician senior job description, begin by listing detailed duties, responsibilities and expectations. We have included biostatistician senior job description templates that you can modify and use.

Sample responsibilities for this position include:

Biostatistician Senior Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Biostatistician Senior

List any licenses or certifications required by the position: SAS

Education for Biostatistician Senior

Typically a job would require a certain level of education.

Employers hiring for the biostatistician senior job most commonly would prefer for their future employee to have a relevant degree such as Master's and Bachelor's Degree in Biostatistics, Statistics, Education, Medical, Communication, Technical, Computer Science, Epidemiology, Mathematics, Healthcare

Skills for Biostatistician Senior

Desired skills for biostatistician senior include:

Desired experience for biostatistician senior includes:

Biostatistician Senior Examples

• Microsoft Word (.docx) .DOCX
• PDF Document (.pdf) .PDF
• Image File (.png) .PNG
• Effectively interacts and presents results to investigators
• May assist and train users on computer programs
• Work with large clinical registry databases to construct patient cohorts and analyze data for comparative effectiveness and epidemiologic research
• Conduct statistical analysis, assist in developing study designs, communicate findings, and assist with preparation of manuscripts for publication in academic journals
• Meet regularly with investigators and under the supervision of a PhD-level methodologist to discuss research findings
• Attend and participate in regular research conferences
• Learn new skills and analytic techniques as needed
• Directs internal and external teams across multifunctional project or functional areas, leads initiatives to gather, organize, and analyze data from different sources such as virology, Case Report Forms, and patient tracking
• Develop statistical analysis plan
• Support other Trial Statisticians in their responsibilities
• PhD in biostatistics or related field and 1 year relevant experience
• Plan valid, efficient and cost effective clinical trials, typically based on outlines provided by Project Statisticians
• Prepare accurate, high quality reports of clinical trials for registration of drugs and biologics, and publications
• Prepare specifications for data analyses by outside vendors as required
• Designing, conducting, analyzing and/or presenting routine trials/studies
• Working with a team to apply statistical methodology to a research question
• In the role as project leader, conducts briefings and participates in technical meetings for internal and external representatives
• Contributes significantly to the design of functional area goals and development
• Directs own technical leadership and project teams to more meaningful and/or productive ends
• To perform duties of a Trial Statistician to support clinical trials within national, regional or international development projects or for marketed products as required
• To contribute to the development of case report forms and to review for consistency with information needs for the protocol
• Show deep understanding of SAS computing package
• Be familiar with other relevant statistical computing packages such as nQuery
• Lead effectively multiple tasks and projects
• Provide statistical support for the clinical development
• He/she will work with the clinical teams in designing clinical studies, writing the statistical analysis plans, conducting the statistical analyses, and providing statistical support for the clinical study reports, scientific presentations and manuscripts
• Writing the statistics section a protocol or analyzing a clinical trial/case study
• Communicating basic statistical information to non-statisticians
• Attention to Detail – Possess a strong quality orientation
• Demonstrated highly advanced expertise in developing and incorporating novel methodologies into current processes and protocols
• Proven ability of excellent cross-functional project management skills, including an impressive track record of consistently meeting all project timelines and objectives
• MS level degree or equivalent in Biostatistics, Statistics or related field
• Oversee junior-level biostatisticians on data cleaning and creation of analytic files and mentor junior-level biostatisticians in the area of conducting collaborative research
• Lead statistical projects related to collaborations on topics including the evaluation of statistical software or methods the development of novel methods, as need arises within QSU collaborative projects
• Consult with clinical and lab-based investigators on campus including the Heart Center, the Department of Medicine, the Department of Neurosurgery, and the Stanford Cancer to independently design studies and develop analysis plans
• Develop oral and written dissemination of findings for meetings with collaborators or for medical and/or statistical journal articles
• Contribute to Business Development activities, proposals and client presentations
• Become familiar with the activities outlined in the department’s Working Practice Documents and contribute changes as needed
• Write / review analysis plans and guide others on the team in its implementation
• Prepare reports, manuscripts, and other documents
• Provide input to the Directors, Associate Directors, and Managers as to hiring recommendations, department policies, and resourcing requirement.Assist in bidding and business development activities
• Perform duties of a Project Statistician to support high profile international development projects/trials or marketed products as required
• The ideal candidate will have at least two years of experience in SAS analysis of clinical trial data, 5-8 yrs preferred
• PhD in Biostatistics or Statistics
• 4–5 years in clinical research working for a nutritional company, or in Phase III trials for a pharmaceutical company
• 1–2 years experience in managing and directing support activity of Clinical Data Management (CDM), programming and statistics personnel, such as working with CROs
• Masters degree or educational equivalent in computer science or related field and 3 years relevant experience
• MS in Statistics or related discipline entry level, relevant work experience in statistical analysis of 8+ years required, including minimum of 5 years as study statistician
• Advise on the design of valid, efficient and cost effective clinical trials and other research projects
• Direct analysis of data from major, prototypical phase II to IV trials incl
• Acts as a Trial or Project Statistician (TSTAT or PSTAT) for the trial/project
• Collaborate with the programming group and the data management group to submit very detailed timelines for the trial/project to clinicians
• Informs management that hours allocated to TSTAT by the capacity algorithm should be updated (follow up the amount of hours entered in the time recording system and related to the trial/project)
• Receives broad operating instructions in performing a majority of duties from manager and keeps manager abreast of programming status
• Perform duties of a Trial Statistician to support complex clinical trials within national or international development projects or for marketed products as required
• Analyze data from phase I to IV trials incl
• Participate on assigned international teams to promote harmonization efforts for clinical drug development
• Collaborate with the Biostatistics group and provide statistical support for research and development, quality initiatives, and complex clinical trial research as needed provide guidance on standards, processes, and other technical topics
• Knowledge of ADaM standards
• Bachelor’s degree or equivalent and 7 + years of experience OR Master’s degree in statistics/biostatistics/mathematics and 4 + years of experience OR PhD in statistics/biostatistics OR PhD in related disciplines with M.S
• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or a Master’s degree with a minimum of 12 years relevant work experience
• Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution
• Extensive use of telephone, face-to-face communication requiring accurate perception of speech and of keyboard requiring repetitive motion of fingers
• Flexibility on travelling
• Provide state-of-the-art statistical strategies to meet business objectives by offering technical direction and leadership
• Resolve complex statistical issues from the business units and external customers
• Review protocols for proposed studies and IIS proposals with respect to statistical methodology as needed
• Provide statistical support during discussions with regulatory agencies
• Contribute to and co-author peer-reviewed articles independently and/or in coordination with the lead author/physician
• Manage resources and priorities
• Follow processes and adhere to our client's and project specific standards Health Authority requirements (SOPs, BGs, Master Analysis Plan, GCP, and regulatory guidelines)
• Performs statistical design, modeling and analyses
• Prepares statistical analysis plans, timelines for statistical project management and performs and interprets complex analyses
• Develop novel approaches to addressing complex problems in NGS data analysis
• To perform statistical analysis, then present and defend interpretation of study results through presentation of abstracts, papers and submission of publications
• To communicate with regulators, consultants, physicians, and other internal and external sources as needed to support submissions, analyses, presentations and publications
• PhD degree in statistics/biostatistics or related discipline with a minimum of 10 years relevant work experience across a broad range of biopharmaceutical statistics research activities
• SAS programming skills and familiarity of other statistical packages
• Experience with SAS Base and SAS Stat, strong data step skills
• Ability to work effectively and cooperatively with other professional staff members

Related Job Descriptions

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Clinical Biostatistics Manager

Clinical Biostatistics Manager manages a clinical biostatistics or health informatics team. Oversees the analysis, management and performance of health information data to aid patient care. Being a Clinical Biostatistics Manager monitors latest software and technology to keep processes up-to-date and efficient. Communicates with analysts, healthcare providers, and management to establish new processes and analyses, and to tailor current data processes to best help providers. Additionally, Clinical Biostatistics Manager requires a master's degree. Typically reports to a director or head of a unit/department. The Clinical Biostatistics Manager typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Clinical Biostatistics Manager typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments.

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• Clinical Data Manager
• Clinical Research Manager
• Clinical Outcomes Manager
• Clinical Informatics Manager
• Clinical Research Associate I
• Clinical Research Associate II
• Clinical Biostatistics Director
• Clinical Informatics Senior Manager
• Clinical Facilities Planning Manager
• IT Project Management and Delivery Manager
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All current open positions affiliated with the Department of Biostatistics and Bioinformatics can be found here.

Multi-Career Track Faculty Positions

The Duke Clinical Research Institute (DCRI), in partnership with Duke University and the Department of Biostatistics and Bioinformatics (B&B), is investing in the growth of Data Science and Biostatistics (DS&B).

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Postdoctoral Associate Positions:   

• Develop high-throughput technologies for studying combinatorial gene regulation (Integrative Genomics: CEGS)
• Statistical methods studying combinatorial gene regulation (Integrative Genomics: CEGS)
• Machine learning and statistical approaches to analyze genetic and genomic data (Integrative Genomics: IGVF)
• Single-cell and spatial data science in pulmonary research
• Develop innovative statistical methods in clinical trial design

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Biostatistician Job Descriptions, Average Salary, Interview Questions

What does a biostatistician do.

Biostatisticians collect data from medical research and analyze it to draw conclusions or make predictions. They develop and execute research studies in collaboration with other statisticians and scientists and monitor clinical trials to ensure the integrity of the results. Biostatisticians must have exceptional written communications skills as they write research proposals and submit their findings to the scientific community. Some biostatisticians may also teach at universities while conducting their research, splitting time between the lab and the classroom. They are required to have an in-depth understanding of advanced statistical techniques, be familiar with analyzing clinical trials, and have excellent knowledge of epidemiology and statistics. The ability to plan, develop, and manage complex statistical computer databases is also important in this role.

Biostatisticians typically work in medical research, pharmaceuticals, public health, and clinical investigations. They should be familiar with specialized computer programs to analyze statistics and lab results. This role requires good collaboration skills as biostatisticians often interact with other scientists and researchers. 

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National Average Salary

Biostatistician salaries vary by experience, industry, organization size, and geography. To explore salary ranges by local market, please visit our sister site zengig.com.

The average U.S. salary for a Biostatistician is:

Biostatistician Job Descriptions

It’s important to include the right content in your job description when hiring a biostatistician. The following examples can serve as templates for attracting the best available talent for your team.

General Biostatistician (sample)

As a biostatistician for [Your Company Name], you’ll design, analyze, and interpret data for scientific research. The biostatistician combines epidemiological knowledge with statistics to work in areas such as medical research, pharmaceuticals, public health, and clinical investigations.

You will interact closely with a research team, so it helps to communicate well. The ability to produce readable reports, which summarize their findings and generate hypotheses, is essential. You must know how to use statistical programs like SAS Software. The ideal candidate should also be familiar with other software packages, including Java Programming Operations Research (JOR) Package, Minitab Statistical Packages, S-Plus Statistical Packages among others.

Typical duties and responsibilities

• Programming knowledge of at least one statistical software package such as SAS, JMP, STATA, or R.
• Statistical analysis of medical research data
• Interpret statistical analysis to draw conclusions on a wide range of topics
• Design and conduct experiments, surveys, observational studies, and clinical trials as needed
• Summarize findings in reports or presentations.
• Communicate with team members regularly via email, phone calls, or meetings.
• Maintain a database of research materials

Education and experience

• Master’s degree in statistics, biostatistics or related field
• Many employers prefer candidates with 5-7 years of experience
• A master’s degree will enable you to apply to entry-level positions in biostatistics
• Some people do choose to pursue a doctoral degree, but this is not necessary

Required skills and qualifications

• Good communication and presentation skills
• Ability to work in a team environment
• Creativity, resourcefulness, and the ability to mentor junior staff
• Knowledge of epidemiology and medical terms is a plus
• Knowledge of public health and clinical trials is a plus

Preferred qualifications

• Knowledge of various statistical software packages including SAS Software, Minitab Statistical Packages, S-Plus Statistical Packages among others
• Able to demonstrate the use of statistical approaches and techniques in analyzing data related to biomedical research
• Knowledgeable about statistical analysis, probability theory, and modeling for generating predictions
• Familiar with Microsoft Excel

Entry-level Biostatistician

Our biostatisticians are responsible for

• Assisting in the analyses of research studies by using appropriate statistical methods and/or mathematical techniques
• Meeting with clinicians, scientists and other research personnel to discuss research projects, goals and hypotheses
• Providing support for statistical analyses by extracting data and ensuring accurate data files
• Using statistical software packages (e.g., SAS and/or R) to write computer programs to analyze data
• Preparing memoranda to effectively document data issues, statistical methodology, and analysis results and interpretations, including results in tabular and graphical forms
• Assisting investigators with abstract and manuscript development to disseminate research results

Duties are performed under the guidance of a faculty member.

Ideal knowledge, skills, and abilities

• Knowledge of statistical methods
• Knowledge of SAS and/or R statistical software
• Strong oral and verbal communication skills, including the ability to effectively communicate statistical methodology and results to non-statisticians
• Excellent organizational and time management skills
• Ability to manage multiple projects with competing deadlines in a professional manner

Candidate may be hired at a career level that best fits her or his individual qualifications

Education requirements

• Master’s Degree in biostatistics, applied statistics, or related field
• Minimum of two (2) years of work experience consistent with that expected of the Statistical Analyst position

Mid-level Biostatistician

As a biostatistician, you will be given access to cutting-edge in-house technology, allowing you to work on global projects across various therapeutic areas. Thanks to our development opportunities and mentoring at all levels, you can progress your long-term career in the direction you choose.

• You will develop statistical methods sections of protocols and review case report forms (CRFs)
• Prepare analysis plans and write specifications for analysis files, consistency checks, tables, and figures
• Communicate with clients regarding study protocol or statistical analysis issues as they arise
• Interpret analyses and write statistical sections of study reports

Key responsibilities

• Act as a statistical lead on single studies
• Working closely with the Project Team Lead and supervisor to deliver on time, with high quality, and within budget
• Writing and performing quality control (QC) reviews of Statistical Analysis Plan (SAP) and Shells
• Writing and maintaining programming specifications. Programming assigned datasets to industry standards
• Assisting with protocol development, sample size calculation and case report form (CRF) review
• Building and maintaining effective customer relationships, driving statistical discussions, providing support, and/or guidance for statistical activities
• Managing scope of work and budget, and providing revenue and resource forecasts for single studies
• Training and mentoring junior staff. Supporting colleagues and providing motivation as needed

Requirements

• BSc or MSc degree in Biostatistics or related field, and 2-4 years relevant experience within the life-science industry
• Familiarity with moderately complex statistical methods that apply to applicable clinical trials
• Good working knowledge of SAS and CDISC
• Ability to effectively manage multiple tasks and projects

Principal Biostatistician

[Company] is a global CRO that offers high-quality one-stop service to biopharmaceutical, medical device, and consumer products clients. Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. [Company] has established major delivery centers across the US, Canada, China, Europe, India, Japan, and the Philippines. It has over 3,000 employees globally, with a strong and talented team and a growing clinical operations presence in seven countries across Asia, North America, and Europe.

The goal of the principal biostatistician is to provide Biostatistical support and work on key client deliverables involving designing and analyzing clinical trials.

Responsibilities

• 3+ years’ experience preferred leading late-phase studies • Modeling experiences such as Mixed Models, Cox Models, Kaplan, Mier Estimates, and Poison Modeling would be a plus·
• Responsible for protocol development, including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
• Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
• Responsible for assuring that data for statistical analyses are complete, accurate, and consistent.
• Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
• Responsible for the validity of the analysis and exploring alternative analysis strategies as needed.
• Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
• Responsible for the accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
• Responsible for the statistical methods section of the reports. Identifies and corrects common flaws in the interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and ensures project-wide consistency.
• Effectively mentor peers about statistical methodology and provide appropriate training to less experienced statisticians.
• Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.
• MS or Ph.D. in Statistics, Biostatistics, or related field. Ph.D. with 3-5 years of experience or MS with 6-8 years of experience.
• Strong oral and written communications skills, with the ability to effectively communicate internally and with clients.
• Demonstrated understanding and insight into statistics, drug development process, and relevant FDA regulations.
• Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.

Research Biostatistician

The primary purpose of the research biostatistician position is to carry out data preparation responsibilities related to cancer clinical trials, develop skilled statistical programs, perform statistical analysis associated with clinical data and prepare written reports to investigators. In addition, this position prepares statistical considerations for basic trial designs or grants and performs biostatistical reviews of protocols.

Key Functions

• Compiles, analyzes and reports statistical data for various projects including, but not limited to manual and computer-aided data abstraction and evaluation, clinical trials, computerized imaging and bioinformatics.
• Prepares statistical considerations for basic trial designs and carries out uncomplicated statistical analyses independently, but completes statistical responsibilities for more complex projects with supervision.
• Assists faculty in the development of new statistical methodology for measurement and analysis of data.
• Applies advanced statistical methods, simulation models, and skilled statistical programming as needed.
• Assesses relevant literature as well as existing data, evaluates the quality of data used in reports and assists with preparation and distribution of data for committee and scientific meetings.
• Attends project meetings with collaborators with or without supervisor as directed by supervisor.
• May present findings at relevant meetings both inside and outside of the institution as requested.
• Participates in the protocol review process jointly with supervisor.
• Prepares written reports to investigators jointly with supervisor.
• Other duties as assigned.

Required: Master’s degree in Biostatistics, Statistics, Bioinformatics, Mathematics or related field.

Preferred: PhD in Biostatistics, Statistics, Bioinformatics, Mathematics, or related field.

Required: Two years experience with mainframe and/or PC databases, document processing and statistical software such as SAS and S-Plus. With preferred degree, no required experience.

Preferred: Statistical software experience with an emphasis in biostatistics and clinical trials.

Biostatistician Qualifications to Look For

Previous experience.

• Collaborated with scientific teams to design robust experiments and clinical trials
• Applied statistical theories and methods to solve complex biological problems
• Collected, analyzed, and interpreted data from biological experiments and trials
• Utilized statistical software such as R, SAS, or SPSS for data analysis and modeling
• Provided insights on findings through reports, graphs, and other visual means
• Reviewed and ensured data integrity and accuracy
• Assisted in the publication of research findings, ensuring statistical soundness
• Contributed to grant writing processes with a focus on the statistical design and analysis components
• Developed new statistical methodologies or adapted existing ones to better meet research needs
• Provided guidance on sample size determination, experimental layout, and data collection methods

Soft skills

• Strong analytical thinking and problem-solving abilities
• Excellent written and oral communication skills
• Detail-oriented  
• Effective collaboration and team-working skills
• Ability to handle multiple projects simultaneously
• Master’s degree in Biostatistics, Statistics, or a related field is often the minimum requirement; however, many positions, especially in academic research or advanced pharmaceutical work, may require a Ph.D.
• Knowledge of specialized statistical software such as R, SAS, or STATA
• For those working on clinical trials, familiarity with regulatory guidelines (like those from the FDA or EMA) can be beneficial
• Continuous learning to stay updated with advancements in both biological sciences and statistical methodologies

Certifications

• Mastering Software Development in R Certification by Johns Hopkins University (Coursera) . This specialization in R programming provides rigorous training in R language and also teaches the best software development practices for building data science tools that are not only robust, modular and reusable but also collaborative (thus suitable for use in team-based and community environments). Through this program candidates will gain the necessary skills for handling complex data, building R packages, and developing custom data visualizations.
• Clinical Trial Programmer Exam:  The certification exam features 90 to 100 multiple-choice questions, a three-hour time limit and candidates must answer at least 70 percent of the questions correctly to pass the exam. There are no prerequisites required to take this exam.
• Clinical Trial Programmer – Accelerated Exam:  The certification exam features 70 to 75 multiple-choice questions, a 120-minute time limit, and candidates must answer at least 70 percent of the questions correctly to pass the exam. Candidates must already have completed the SAS Base Programmer certification before they can sit for this accelerated exam.
• Certificate in Applied Biostatistics – Online (Harvard Catalyst) . This advanced-level program is for candidates with MD, Ph.D. or equivalent degrees. The comprehensive classes provide a comprehensive introduction to biostatistics in medical research. Review the common techniques in this field as well as the manners in which they can be applied in standard statistical software. End the lectures by choosing an appropriate study design, calculate the sample size needed to complete the study, analyze the collected data, and communicate the results from their experiments.

How to Hire a Biostatistician

When hiring a biostatistician, first consider the following:

• Recruiting:  Do you have the knowledge, tools, and resources to attract and screen candidates?
• Complexity:  Do you need a senior professional, or will mid or junior-level skills and experience suffice?
• Duration:  Is this a one-time project or an ongoing need?
• Management:  Do you have the time and expertise to direct the work effectively?
• Urgency:  How soon does the work need to be completed?
• Headcount:  Do you have the budget and approval for an internal employee, or should you consider alternate options?

Answering these questions will help determine the best course of action for your current hiring need. Fortunately, great options exist for every scenario. These are our recommendations:

1. Use 4 Corner Resources (or another professional recruiting firm)

The heavy lifting is done for you when working with a top-tier staffing company like 4 Corner Resources. We source, screen, recruit, and deliver only the most qualified candidate(s), saving you significant time and effort throughout the hiring process while you remain focused on your core business. Understanding your needs and ensuring the right candidate for the position is the key to our success.

This is the best route to take when:

• You need to fill the position quickly
• You want access to a vast talent pool of high-quality, prescreened candidates
• Your position is suited for temporary hiring services , contract staffing , or contract-to-hire recruiting , and you intend to direct the work activity.
• You are hiring an employee as a direct placement but aren’t able to recruit effectively or efficiently with your internal staff. 
• You aren’t familiar with current salary rates, market trends, and available skill sets

2. Advertise your opening on a top job board

Your best option may be to advertise your opening on a proven job board. There are many widely used job sites out there that draw visits from qualified candidates. If you have someone internally who can dedicate the time and energy to sort through applications and screen individuals effectively, this can be a great choice. 

We recommend using a job board when:

• Your internal recruiting team has the knowledge and experience to assess candidate qualifications
• You are hiring a direct employee and have time to manage the entire recruiting effort 
• You have a process for receiving, screening, and tracking all resumes and applications
• You are prepared to respond to all applicants

We recommend using CareerBuilder when hiring a biostatistician:

CareerBuilder

CareerBuilder has been a trusted source for hiring since 1995. Reach 80+ million unique, diverse U.S. job seekers annually by posting your jobs through their talent acquisition channels. Through CareerBuilder, you can engage candidates and drive them into your sourcing pipeline. We recommend using CareerBuilder for hiring when you have the internal resources and processes to review, screen, and reply to all applicants.

3. Leverage your internal resources

You can utilize your own website, social media, and employees to assist in your search for top candidates. 

A company website posting should be the first step in notifying prospective candidates that you are hiring. Social media can also be a powerful tool for spreading the word about your new opening. As far as exposure is concerned, this option can be as good as some job boards when you have a large enough following across various platforms, like LinkedIn, Instagram, Facebook, TikTok, and Twitter.

Current employees are every organization’s greatest asset. Encourage your internal team to promote job openings to their network by offering cash and other incentives.

We recommend these options when:

• Your brand has great name recognition
• You can consistently monitor and respond to candidate activity through your website and social media accounts
• You have a process in place to quickly and broadly communicate job openings and requirements
• You have an effective employee referral program in place

If you aren’t sure which path is best,  schedule a discovery call today with our seasoned recruiting professionals. The 4 Corner team is on standby to help you find the best option for your unique hiring need.

Sample Interview Questions

• Can you explain your experience with statistical analysis and modeling in a biomedical or clinical research setting?
• How do you design and implement statistical analysis plans for clinical trials or other studies?
• Can you give an example of a project where you had to account for multiple confounding factors or missing data in your analysis?
• How do you ensure the validity and reliability of your statistical analyses?
• How do you communicate complex statistical concepts and results to non-statisticians in a clear and understandable manner?
• Can you describe a situation where you had to adapt your analysis methods or change your study design based on new data or unexpected results?
• How do you ensure compliance with regulatory requirements and guidelines for statistical analysis in clinical research?
• How do you use statistical software and programming languages for data analysis and visualization?
• Can you describe a time when you had to use advanced statistical techniques, such as survival analysis or mixed effects models, in your work?
• How do you stay current on advances in statistical methods and their applications in biomedical research?

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What is a Biostatistician?

A Biostatistician is a statistical expert specializing in the design, analysis, and interpretation of data in biological, medical, and health-related research. Biostatisticians develop and apply statistical methods to address research questions, evaluate hypotheses, and draw conclusions from data collected in observational studies, clinical trials, epidemiological investigations, and other research studies. Their work informs decision-making processes, guides policy development, and contributes to advancements in healthcare and public health practice.

Biostatistician Job Description

Are you passionate about applying statistical methods to solve complex problems in biology, medicine, and public health? If so, we’re seeking dedicated individuals to join our team as Biostatisticians. As essential members of our research community, successful candidates will play a pivotal role in designing studies, analyzing data, and drawing meaningful insights to advance scientific knowledge and improve human health outcomes.

As a Biostatistician, you will have the opportunity to collaborate with interdisciplinary teams of scientists, healthcare professionals, and policymakers to tackle critical health issues, inform evidence-based practices, and drive innovation in healthcare delivery and disease prevention.

The ideal candidate will possess a strong foundation in statistics, proficiency in statistical software, and a passion for applying quantitative methods to address real-world challenges in biology and medicine.

What Does a Biostatistician Do?

Study Design and Planning:

• Collaborate with researchers, clinicians, and study sponsors to design research studies, clinical trials, and epidemiological investigations, including sample size calculation, randomization, and protocol development, to ensure study objectives are met and data quality is maintained.
• Develop statistical analysis plans (SAPs), including data management, analysis methods, and statistical techniques, to address research questions, test hypotheses, and generate robust and reliable results.

Data Analysis and Interpretation:

• Analyze research data using appropriate statistical methods, including descriptive statistics, inferential statistics, regression analysis, survival analysis, and longitudinal data analysis, to explore relationships, detect patterns, and draw conclusions.
• Interpret study findings, summarize results, and present findings in scientific publications, conference presentations, and research reports to communicate research outcomes and contribute to scientific knowledge and discourse.

Statistical Programming and Software:

• Utilize statistical software packages, such as R, SAS, SPSS, or STATA, to conduct data analysis, perform statistical tests, and generate graphical representations of data to facilitate data exploration, visualization, and interpretation.
• Develop and maintain data analysis scripts, macros, and programs to automate data processing, ensure reproducibility, and streamline analysis workflows in compliance with best practices and industry standards.

Collaboration and Communication:

• Collaborate with multidisciplinary teams of scientists, researchers, clinicians, and stakeholders to integrate statistical methods into research projects, provide statistical consultation, and support data-driven decision-making processes.
• Communicate statistical concepts, methodologies, and results to non-statistical audiences, including researchers, clinicians, policymakers, and the public, in clear, concise, and accessible language to facilitate understanding and application.

Quality Assurance and Regulatory Compliance:

• Ensure data integrity, accuracy, and quality control throughout the research process, including data collection, entry, cleaning, and analysis, to maintain data reliability and validity and comply with regulatory requirements and ethical standards.
• Participate in data monitoring committees (DMCs), safety monitoring boards (SMBs), and regulatory submissions, such as Investigational New Drug (IND) applications and New Drug Applications (NDAs), to ensure research compliance and patient safety.

How Much Do Biostatisticians Make?

The average Biostatistician salary in the United States is $77,077 as of February 26, 2024, but the range typically falls between $68,800 and $89,857.

Skill Requirements

• Statistical Methods and Techniques: Biostatisticians must possess a strong understanding of statistical methods, including hypothesis testing, regression analysis, survival analysis, and longitudinal data analysis, to analyze complex research data and draw meaningful conclusions.
• Statistical Software Proficiency: Biostatisticians should have proficiency in statistical software packages, such as R, SAS, SPSS, or STATA, to conduct data analysis, perform statistical tests, and generate graphical representations of data efficiently and accurately.
• Research Design and Methodology: Biostatisticians must have knowledge of research design principles, study methodologies, and clinical trial regulations to contribute to study design, protocol development, and data analysis planning effectively.
• Communication and Collaboration: Biostatisticians should have strong communication skills and the ability to collaborate effectively with interdisciplinary teams of scientists, researchers, clinicians, and stakeholders to integrate statistical methods into research projects and communicate findings.
• Critical Thinking and Problem-Solving: Biostatisticians must demonstrate critical thinking skills and the ability to formulate research questions, design analysis plans, and troubleshoot data analysis problems to address research challenges and advance scientific knowledge.

Example KPIs for a Biostatistician

• Research Impact and Publication Productivity: This KPI measures the impact and productivity of a biostatistician’s research output, including publications, citations, and collaborations, to assess research influence and contribution to the scientific community.
• Data Analysis Accuracy and Validity: This KPI evaluates the accuracy, validity, and reliability of a biostatistician’s data analysis methods, statistical models, and research findings to ensure data integrity and support evidence-based decision-making processes.
• Collaborative Engagement and Communication: This KPI assesses a biostatistician’s engagement in collaborative research projects, interdisciplinary partnerships, and effective communication with stakeholders to facilitate knowledge exchange and research dissemination.
• Regulatory Compliance and Ethical Standards: This KPI measures a biostatistician’s adherence to regulatory requirements, ethical standards, and best practices in research design, data analysis, and reporting to ensure research integrity and protect participant rights and welfare.

How Can Glider AI Help You with Hiring a Biostatistician?

Glider’s recruitment platform is designed to streamline the hiring process for Biostatisticians by prioritizing competency over credentials. Utilize Glider AI Skill Intelligence™ to identify top-quality candidates, streamline candidate screening, and ensure a mobile-first, candidate-friendly experience.

Glider AI’s Unique Features

• Verify Medical Licenses
• Validate Hundreds of Medical, Clinical, and Technical Skills
• Ensure Hiring Compliance
• Conversational Chatbot for Talent Screening
• Powerful candidate analytics
• Streamline Healthcare Hiring with AI and Automation

Go ahead and spotlight your Biostatistician with Glider AI today!

Schedule a Demo  or contact us at  [email protected]

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Senior Biostatistician

Job description overview.

A Senior Biostatistician job description involves the application of statistical methods to biomedical research, such as clinical trials and other health-related studies. They play a crucial role in designing research studies, analyzing data, and interpreting results. Senior Biostatisticians must possess strong analytical skills, as well as knowledge of statistical software and programming languages. They work closely with other professionals, including researchers, physicians, and data managers, to ensure that research objectives are met and accurate data is collected. Senior Biostatisticians also contribute to the development of research protocols, assist in the preparation of grant proposals, and offer guidance on statistical methodology. Overall, this position requires advanced knowledge of statistical analysis and a passion for using data to improve human health. A background in biology, epidemiology, or public health is typically required, as well as a Master's or PhD in biostatistics or a related field.

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Table of contents, job duties and responsibilities.

• Design and develop statistical analysis plans for clinical trials in collaboration with researchers and scientists.
• Conduct statistical analyses of data generated during clinical trials.
• Collaborate with cross-functional teams to ensure that statistical analyses are accurate and in alignment with project goals.
• Define and drive the development of statistical methodologies, tools and platforms for data analysis.
• Provide statistical and technical expertise in presenting and publishing study results.
• Develop and review statistical sections of clinical trial reports, abstracts, manuscripts, and regulatory submissions.
• Mentor and train junior biostatisticians, programmers and members of cross-functional teams.
• Stay up-to-date on industry standards and advancements in biostatistical analysis tools and techniques.
• Ensure that clinical trials comply with regulatory requirements and ethical standards.
• Communicate effectively with project teams and stakeholders to ensure successful project completion.

Experience and Education Requirements

To become a Senior Biostatistician in the Science industry, you typically need an advanced degree in statistics, mathematics, or a related field. This could be a Master's or a Ph.D. degree. You also need experience working in the field of Biostatistics. Many employers prefer candidates with at least 5 to 7 years of experience, working as a Biostatistician in the healthcare or pharmaceutical industry. A Senior Biostatistician must have strong analytical and problem-solving skills. They must be able to interpret and analyze complex data, and communicate their findings effectively to others. Additionally, proficiency in statistical software such as SAS, R, or SPSS is often required.

Salary Range

Salaries for Senior Biostatisticians in the science industry vary depending on numerous factors such as location, experience, and company size. In the United States, the expected salary range for a Senior Biostatistician is between $100,000 to $150,000 per year. However, this range can go as high as $250,000 or more in some cases. According to Glassdoor, the national average salary for senior biostatisticians is around $128,000. Similarly, in Canada, the average salary for this position is around CAD 98,000 per year.

Other factors that could influence salary range include academic qualifications, scope of responsibilities, and technical skills. In general, pharmaceutical companies and research organizations offer higher salaries for this position compared to government or academic institutions. The senior biostatistician plays a crucial role in clinical trials, disease control, and drug development.

• https://www.glassdoor.com/Salaries/senior-biostatistician-salary-SRCH_KO0,22.htm
• https://www.payscale.com/research/CA/Job=Senior_Biostatistician/Salary
• https://www.salaryexpert.com/salary/job/senior-biostatistician/united-states

Career Outlook

The career outlook for a Senior Biostatistician in the Science industry is excellent and is expected to grow in the next five years. The job prospects for this field are expected to increase by 8% from 2019 to 2029, faster than the average for all occupations. An increasing demand for Senior Biostatisticians is due to the rising prominence of big data and analytics in the healthcare industry. With the significant growth of this industry, the need for qualified and experienced Senior Biostatisticians is expected to surge.

According to the Bureau of Labor Statistics, the median salary for a Senior Biostatistician in May 2020 was $98,230. PayScale's data further supports this trend with a reported average salary of $112,000 for Senior Biostatisticians.

In conclusion, the career prospects for Senior Biostatisticians indicate a positive trend in the Science industry. The demand for this occupation is expected to grow, thereby creating more job opportunities with above-average salaries.

Frequently Asked Questions (FAQ)

Q: What does a Senior Biostatistician do?

A: A Senior Biostatistician uses statistical methods to analyze scientific data in the medical and life sciences field, to support and guide clinical trials, and to publish research papers.

Q: What kind of skills do I need to become a Senior Biostatistician?

A: To become a Senior Biostatistician, you need a graduate degree in statistics or biostatistics, proficiency in statistical programming languages like SAS or R, knowledge of clinical trials, familiarity with statistical methods, and excellent communication and problem-solving skills.

Q: What are some example job duties of a Senior Biostatistician?

A: Some job duties of a Senior Biostatistician include developing statistical analysis plans, designing clinical trials, analyzing and interpreting data, collaborating with cross-functional teams, presenting results to stakeholders, and mentoring junior team members.

Q: What industries employ Senior Biostatisticians?

A: Senior Biostatisticians are employed across many industries, including pharmaceuticals, biotechnology, academia, government agencies, clinical research organizations, and medical device companies.

Q: What is the job outlook like for Senior Biostatisticians?

A: The job outlook for Senior Biostatisticians is positive, with faster than average job growth projected due to the increasing demand for clinical research in the medical and life sciences field.

Job Descriptions:

Senior quality control analyst, molecular biologist, project manager, manufacturing manager, clinical trial associate.

Biostatistics: A Cornerstone of Clinical Research

Clinical research plays a vital role in the development and evaluation of new medical treatments and interventions. It involves rigorous scientific investigation to gather evidence on the safety and efficacy of pharmaceutical products, medical devices, and therapies. 

Biostatistics, a field that combines statistical analysis with biomedical research, is a crucial component of clinical research. 

In this article, we will explore the significance of biostatistics in clinical trials, its role in ensuring data integrity, and the impact it has on regulatory compliance.

The Importance of Biostatistics in Clinical Trials

Biostatistics provides the foundation for designing, implementing, and analyzing clinical trials. It enables researchers to make informed decisions based on statistical principles and methods. The primary goal of biostatistics in clinical trials is to ensure that the sample size is adequate to draw valid conclusions, minimize bias, and account for variability in the study population.

Designing Robust Clinical Trials

Designing a robust clinical trial is essential to generate reliable and meaningful results. Biostatisticians play a crucial role in determining the optimal sample size, randomization methods, and statistical analysis plan. They use statistical techniques to calculate the sample size required to detect a clinically significant effect with sufficient power and to minimize the risk of type I and type II errors.

Statistical Analysis and Interpretation

Once the data is collected, biostatisticians employ advanced statistical methods to analyze and interpret the results. They apply techniques such as hypothesis testing, regression analysis, survival analysis, and non-parametric methods to extract meaningful insights from the data. Biostatisticians also ensure that the analysis is conducted in compliance with regulatory guidelines and industry standards.

Ensuring Data Integrity in Clinical Trials

Data integrity is of paramount importance in clinical trials. Biostatistics plays a vital role in ensuring the quality and accuracy of the data collected during the trial. By implementing rigorous data management processes, biostatisticians contribute to the reliability and validity of the study findings.

Data Management and Standardization

Biostatisticians collaborate with data managers to develop data management plans, ensuring standardized data collection, coding, and storage practices. They ensure that the data is complete, accurate, and consistent, reducing the risk of errors and facilitating efficient analysis. Biostatisticians also adhere to CDISC (Clinical Data Interchange Standards Consortium ) standards for data collection and analysis, enhancing data interoperability and comparability across studies.

Statistical Programming for Data Analysis

Statistical programming is a critical aspect of biostatistics in clinical trials. Biostatisticians use programming languages like R or SAS® to perform complex statistical analyses, generate tables and graphs, and visualize the study results. They ensure that the programming code is well-documented, reproducible, and adheres to industry best practices.

Data Quality Oversight

Biostatisticians implement data quality oversight methods to identify patterns of data issues that may not be apparent through standard data processing techniques. They analyze data from multiple sites, countries, and patients to identify outliers and potential sources of bias. By detecting and addressing data issues early on, biostatisticians contribute to the overall quality and integrity of the trial results.

Regulatory Compliance and Biostatistics

Regulatory bodies, such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency), impose stringent requirements on the design, conduct, and analysis of clinical trials. Biostatistics plays a crucial role in ensuring compliance with these regulatory guidelines.

CDISC Standards and Data Submission

Regulatory agencies, such as the FDA, prefer data to be submitted following the CDISC standards . Biostatisticians ensure that the clinical trial data are mapped and formatted according to these standards, facilitating regulatory review and analysis. This standardized approach enhances data integrity, comparability, and regulatory compliance.

Electronic Data Capture and Remote Monitoring

Technologies like electronic patient-reported outcomes ( ePRO ) and electronic data capture ( EDC ) are revolutionizing data collection in clinical trials. These technologies enable remote participation, enhance data accuracy, and streamline data management processes. Biostatisticians utilize these tools to ensure secure and efficient data capture, leading to improved data quality and faster analysis.

Data Visualisation and Real-time Monitoring

Data analysis technologies are advancing alongside data capture tools. Biostatisticians leverage visualization techniques to provide real-time insights into study progress and data quality. By using industry-recognized visualization tools, they can detect erroneous data and outliers, enabling early intervention and improving overall study quality.

Integration or Third-Party Data and Wearable Devices

The integration of third-party data sources and wearable devices is becoming increasingly prevalent in clinical research. Biostatisticians work with these diverse datasets, ensuring data quality, compatibility, and adherence to regulatory standards. They analyze data from wearable devices like activity trackers, providing additional insights into patient compliance and treatment efficacy.

Biostatistics is a cornerstone of clinical research, playing a pivotal role in study design, data analysis, and regulatory compliance. Biostatisticians ensure the integrity and quality of clinical trial data, enabling researchers to draw valid conclusions and make evidence-based decisions. 

As the field continues to evolve, innovations in biostatistics and clinical data management are shaping the future of clinical research, driving efficiency, and improving patient outcomes. By leveraging the power of biostatistics, researchers and regulatory authorities can confidently navigate the complex landscape of clinical trials and bring innovative therapies to patients worldwide.

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Biostatistician job profile

What does a biostatistician do?

A biostatistician is a type of statistician that uses information about public health and well-being to conduct clinical research into the effects and risk-factors of treatments. They collect, analyse and summarise data based on disease rates or genetics, for example, to produce statistics and conclusions about medicine and how it affects humans. These findings are then distributed to the scientific community or used within businesses to shape their products.

Job description

Exact responsibilities may vary depending on the type of company, however a biostatistician will generally:

• Consider questions relating to the health of people and collect general information from databases or past studies
• Identify gaps in the data and design, implement and run clinical research trials to improve medical knowledge and produce new findings
• Analyse the collected information to determine the effectiveness and risk-factors of treatments on the human population based on various factors
• Work closely with subject experts such as cancer biologists or infectious disease specialists, as well as those conducting the clinical research
• Develop new methods or recommendations

Types of employers

Biostatisticians can work within a variety of different scientific organisations, including:

• Pharmaceutical companies
• Biotechnology companies
• Universities
• Government agencies
• Healthcare corporations

To find out who’s hiring right now, search biostatistician jobs here .

Qualifications and experience required

You will generally be required to hold a higher degree such as a Masters or PhD to become a biostatistician. Many individuals working in this career undertake an undergraduate degree in a relevant subject such as mathematics, statistics or biology first, before specialising in their higher studies through projects or modules. Though there are some entry-level opportunities available, holding a postgraduate qualification will open up the door to more career prospects and advancement.

In terms of work experience, it can be very beneficial to have hands on experience managing statistical aspects of clinical studies and with things such as SAS Programming and CDISC. This can be done alongside either your undergraduate or postgraduate studies (or both) and will help you learn more about the different processes and tools needed within biostatistics, as well as the relevant regulations to follow. Familiarity with analysis methods and specialised software is also useful, although some training will usually be offered at the beginning of a role.

It may be possible to attain an entry-level position before moving into a specialised biostatistician role. You could work as a research assistant , clinical research associate or statistician to gain experience in the clinical/scientific environment and broaden your knowledge, as well as prove your interest in the industry.   

Download CV and cover letter templates to effectively showcase your education and experience here .

How to become a biostatistician

The skills you will need to become a biostatistician include:

• Strong analytical and observational abilities
• Technical and IT skills
• Numerical skills
• Excellent communication skills, both written and verbal
• The ability to problem-solve and think logically
• Organisational skills
• Leadership skills

Within an interview, you are likely to be asked questions that explore your familiarity with specific analysis methods and technology. An employer may also want to hear about your experience with designing and running clinical research trials, as well as your ability to communicate with important stakeholders. Some specific questions you might be asked within a biostatistician interview include:

• Explain how you would approach working with a large amount of data
• Describe an experience where you analysed information and evaluated the results to identify a solution to a problem
• Give me an example of when you have successfully used your creative or logic skills to solve a problem
• What methods do you use to prepare data for processing?
• What are some long-term objectives you implemented in your last company, and how did you ensure they were met?

There are a variety of ways to search for biostatistician jobs, depending on the type of company you are aiming to work for. Job websites such as Pharmiweb and Emed are a great place to start, as well as clinical publications. You may also find opportunities listed on professional networking sites such as LinkedIn. Specialist recruitment agencies, such as CK Clinical, are another effective way to search for and land jobs, as they are able to offer tailored support and advice.

Sign up to CK+ to apply for vacancies at the click of a button and receive job alerts straight to your inbox here .

Salary expectations

The base or entry-level salary for a biostatistician is around £25,000. Average salaries for experienced individuals can vary hugely depending on the location of the role and type of company, however they will usually range between £35,000 and £55,000.

Career path and progression

There are a number of different opportunities can be presented to biostatisticians, such as:

• Within a pharmaceutical or biotechnology company you could gain responsibility for all statistical activities for the development of a specific drug or therapeutic area
• Within a clinical research organisation (CRO) you could gain more project management responsibilities and be involved in budgeting or planning
• Within a contracting environment you could undertake flexible working and assist projects with a range of different organisations

Related jobs

• Statistician – collects, analyses and interprets quantitative data in order to find innovative and practical solutions to a company’s problems as well as make trend predictions.
• Clinical Data Manager – responsible for ensuring that statistical information and results from clinical trials are recorded and reported accurately, both during and after they are complete.
• Medical Writer – works alongside scientists, doctors and other healthcare professionals to produce physical and online medical documents for educational, promotional or informative purposes. 

Read our interview with a biostatistician

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How a CU Biostatistician is Helping Improve Palliative Care Research

Kathryn colborn, phd, msph, helps palliative care investigators collect meaningful data through her leadership in the palliative care research cooperative group..

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If a person is diagnosed with a serious illness like dementia, heart failure, or cancer, they may begin to receive a specialized type of medical care called palliative care, which focuses on improving the quality of life of both patients and their caregivers. 

Each year, an estimated 56.8 million people are in need of palliative care, the World Health Organization said in 2021. However, despite a growing demand for palliative care due to an aging population, there are gaps in research and evidence within the field, according to a 2020 article published in the Journal of Aging Research. 

The need for further research on palliative care is clear — but how can investigators best collect and share their data? That’s when Kathryn Colborn , PhD, MSPH, enters the conversation. 

Since 2016, Colborn, an associate professor in the Division of Health Care Policy and Research at the University of Colorado Department of Medicine , has co-directed the Data, Informatics, and Statistics Core (DISC) of the Palliative Care Research Cooperative Group ( PCRC ), an interdisciplinary research community made up of more than 600 members across the country. 

“People do really robust science in palliative care,” Colborn said. “It’s rigorous research but it’s hard because the outcomes can be difficult to define and measure. There are reliable tools for measuring quality of life, but there are a lot of things that happen between an intervention and its impact on quality of life that should be addressed. We often refer to these as mechanisms”. 

“Finding those intermediate outcomes on the causal pathway are really important,” she added. “We need to really think about what is causing the effect and how we can best measure that.” 

For example, cancer patients experience a lot of pain toward the end of life, she said. A palliative care intervention might first target improving patients’ knowledge of pain coping skills, which would impact the patients’ daily pain scores, and eventually, their quality of life.

Applying her skills as a biostatistician, Colborn co-leads the PCRC’s data repository and helps mentor palliative care investigators on how they can best set up their research and clinical trials to collect meaningful data. As a result of her leadership, Colborn was asked to lead the data coordinating center of a roughly $19 million palliative care research project funded by the Patient-Centered Outcomes Research Institute (PCORI) that will continue through 2028. 

“We’ve made a lot of progress on engaging patients to understand what they think is important, and caregivers as well. We’ve figured out how we can design real-world, pragmatic research studies in robust ways and some advances in statistical methods in order to analyze those in robust ways,” said Colborn, who also directs the Biostatistics and Analytics Core at the Adult and Child Center for Outcomes Research and Delivery Science (ACCORDS). 

“I think our field has really changed over the last decade, and I believe that the PCRC has been a big part of that,” she added. 

The PCRC’s evolution 

More than 14 years ago, a group of senior palliative care investigators, methodologists, and clinicians came together to form the PCRC to help build an evidence base that supports the clinical practice of palliative medicine.  

The group officially launched with a meeting at the CU Anschutz Medical Campus in January 2010, according to an article published in the Journal of Palliative Medicine. A host of the meeting was University of Colorado Hospital Chief Medical Officer Jean Kutner , MD, MPH/MSPH, whose research focuses on palliative care and hospice. 

“Palliative medicine has made rapid progress in establishing its scientific and clinical legitimacy, yet the evidence base to support clinical practice remains deficient in both the quantity and quality of published studies,” the article said.

The PCRC aimed to address this by applying a cooperative group framework to “help overcome many obstacles to palliative care research, such as lack of standardized definitions and processes, small populations in clinical trial sites, and uneven distribution of expertise,” according to the article. 

The PCRC has facilitated or supported many multi-site trials over its 14 year existence, Colborn said. It also developed a library of standardized data elements, which was provided to investigators across the cooperative group to encourage collection of important measures using common definitions, such as self-reported gender, primary patient diagnosis, and self-reported race and ethnicity. The PCRC also hosts a library of serious illness and palliative care patient and caregiver outcome measurement tools that are valid and reliable.

Since its formation, the cooperative group has grown to have more than 600 members and a national network of 220 locations. 

“We really help palliative care researchers … jumpstart their careers, because it can be hard when you’re spread across the country and there aren’t a lot of people in that space at your own institution,” said Colborn, who joined the PCRC in 2015.

“We’re providing a resource to help people build their careers in palliative care, do robust, reproducible research, and network with other people working in the field,” she said. 

The PCRC offers some grants for pilot studies, gives consultations to investigators who need help developing and/or designing their trial or study, and helps investigators set up multi-site trials. 

It also offers clinical trial intensives, which are short workshops in which members of the PCRC teach palliative care investigators how to design their clinical trial and write a grant. 

“The mentorship is one of my favorite parts, going to these intensives and answering people’s questions about the design and analysis of their studies,” Colborn said. “It’s a great way to give back and help others who are early in their careers.”

Leading data collection in a major way 

Given the various roles the PCRC serves, it is structured into several different centers and cores, including the Data, Informatics, and Statistics Core (DISC), which Colborn co-leads. 

The DISC hosts a de-identified quantitative data repository , which is a hub of valuable information that palliative care investigators can access through the PCRC’s website. 

“We have a large data repository of palliative care and serious illness clinical trials, and other types of studies, where people can go online and request to use these data for secondary research purposes,” Colborn said. 

Highlighting the value of these types of databases, Colborn said she thinks palliative care investigators should try to use them more often when conducting research. 

“In palliative care, there are a lot of studies doing primary data collection — which is great, but it is expensive. It also takes longer to get an answer to a research question,” she said. “There are studies that can be done using our repository data … that are cheaper to do and quicker.”

Colborn’s leadership in the PCRC is a big part of the reason why she was asked by the principal investigators of a roughly $19.2 million research project to lead the project’s data coordinating center.  

The research project aims to compare two ways of providing palliative care to improve the quality of life of patients who have acute myeloid leukemia, a type of blood cancer. The multi-year project involves 1,150 adults with high-risk acute myeloid leukemia who are receiving intensive chemotherapy, as well as their caregivers. 

“They reached out to us because they wanted the PCRC DISC that I lead — the data, informatics, and statistics core — to support this large trial,” Colborn said. 

The study is just one of many Colborn has aided throughout her time at the PCRC. Although it can be time consuming, helping palliative care investigators conduct meaningful research is something Colborn is passionate about. 

“It’s such a great population of investigators,” Colborn said about the people she works with. “It feels like a family.” 

Where data and mentorship combine

In addition to hosting the data repository, the DISC offers guidance to palliative care investigators, helping ensure they are appropriately tracking their clinical trials, implementing strong data documentation, and conducting reproducible research, Colborn said. This type of mentorship is valuable, especially given the complexities of the field. 

“There are a lot of statistical methods challenges in palliative care research,” Colborn said. 

For example, if a palliative care investigator is researching the effectiveness of a certain intervention and wants to look at patients’ quality of life at 12 weeks following the intervention, there is a possibility that some of those patients may die before the investigator gets their final outcome measurement, she said.  

“You have to have sophisticated statistical models to try and handle this bias that occurs, because if you just analyze the people who’ve made it to that time point, then you’re only analyzing the healthiest people in your study,” Colborn said. 

Another challenge can be designing large, pragmatic cluster randomized trials when palliative care investigators face limited resources, she said. To help investigators develop a statistical analysis plan for randomized trials in palliative care, Colborn helped co-write a paper, published in the Journal of Pain and Symptom Management , that walks them through the process.

These types of challenges underscore the value and importance of having consultations with biostatisticians like Colborn. 

“I think we need more collaborative biostatisticians in this world — there aren’t enough of us,” she said. “It'd be great if we could find more people who are interested in going into this field to support these studies.”

SPECIAL NOTE: Much of this work has been possible thanks to Jean Kutner, who has been the multiple principal investigator (MPI) of the PCRC since its formation. The National Institute of Nursing Research has offered several funding renewals for the PCRC to continue its work (funding citations: 1UC4NR012584, 5U2CNR014637, 5U24NR014637.) While the focus of this article was on biostatistics in palliative care research, we want to recognize her essential leadership of the PCRC.

Topics: Research , Patient Care , Palliative care

Kathryn Colborn, PhD, MSPH

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