What Does a Biostatistician Do?
A biostatistician uses statistical techniques to analyze and interpret data in the fields of healthcare, biology, and public health. They play a central role in designing experiments, clinical trials, and observational studies, applying mathematical models to assess the effectiveness of treatments, identify trends, and inform decision-making in medical research.
Biostatisticians collaborate with scientists, researchers, and regulatory bodies to ensure that studies are methodologically sound and results are statistically valid. Their insights contribute directly to medical advances, disease prevention strategies, and policy recommendations based on evidence-driven outcomes.
Looking to Hire a Biostatistician?
Speak with one of our recruiting experts today.
Biostatistician Core Responsibilities
- Design, implement, and analyze clinical trials and epidemiological studies
- Develop statistical models to interpret complex biological or health-related data
- Prepare and validate statistical analysis plans and protocols
- Conduct hypothesis testing, regression analysis, and survival analysis
- Use statistical software (e.g., SAS, R, STATA) to perform data analysis
- Collaborate with researchers, clinicians, and regulatory teams on study design
- Ensure compliance with FDA, NIH, or other regulatory standards
- Interpret results and contribute to scientific publications and presentations
- Monitor data quality and implement quality control processes
- Communicate findings to stakeholders through charts, summaries, and reports
Required Skills and Qualifications
Hard skills
- Expertise in statistical software such as SAS, R, and Python
- Deep understanding of experimental design and hypothesis testing
- Proficiency in multivariate analysis, survival analysis, and clinical trial statistics
- Knowledge of regulatory requirements (FDA, ICH, GCP)
- Familiarity with data cleaning, validation, and integrity monitoring
Soft skills
- Strong critical thinking and problem-solving abilities
- Excellent written and verbal communication
- Collaboration and teamwork across multidisciplinary research teams
- Ability to translate complex statistical findings into clear conclusions
Educational requirements
- Master’s degree in biostatistics, statistics, public health, or a related field (PhD preferred for senior roles)
Certifications
- None required, but certifications in clinical research (e.g., ACRP, SOCRA) or SAS programming may be advantageous
Preferred Qualifications
- Experience working in a pharmaceutical, CRO, or healthcare research environment
- Familiarity with real-world evidence (RWE) and electronic health record (EHR) datasets
- Prior authorship or contribution to peer-reviewed publications
- Exposure to machine learning or advanced modeling techniques
National Average Salary
Biostatistician salaries vary by experience, industry, organization size, and geography. Click below to explore salaries by local market.
The average national salary for a Biostatistician is:
$95,689
Sample Job Description Templates for Biostatisticians
Junior Biostatistician
Position Overview
A Junior Biostatistician supports data analysis efforts in clinical research, public health studies, or medical investigations. This entry-level role is ideal for recent graduates or early-career professionals seeking to apply statistical methods to real-world health data.
Junior Biostatistician Responsibilities
- Assist in developing statistical analysis plans and data protocols
- Perform basic statistical analyses using SAS, R, or STATA
- Clean, organize, and validate raw datasets for accuracy
- Support senior statisticians with model development and reporting
- Prepare tables, charts, and visualizations for study documentation
- Participate in team meetings to discuss study objectives and timelines
Junior Biostatistician Requirements
Hard skills
- Proficiency with at least one statistical programming language
- Understanding of descriptive statistics and regression techniques
- Familiarity with clinical data structures or health datasets
Soft skills
- Detail-oriented and analytical mindset
- Willingness to learn and adapt quickly
- Strong written and verbal communication skills
Educational requirements
- Bachelor’s or master’s degree in biostatistics, statistics, or a related field
Senior Biostatistician
Position Overview
A Senior Biostatistician designs, analyzes, and interprets complex clinical or epidemiological studies. This role leads statistical planning and ensures that research adheres to regulatory and scientific standards.
Senior Biostatistician Responsibilities
- Develop and oversee statistical methodologies for clinical trials or studies
- Create and validate statistical analysis plans and data models
- Perform advanced modeling techniques, including survival and mixed models
- Ensure compliance with FDA, EMA, and ICH-GCP guidelines
- Present findings to internal teams and regulatory agencies
- Mentor junior team members and review their statistical output
Senior Biostatistician Requirements
Hard skills
- Advanced expertise in SAS, R, and statistical modeling techniques
- Strong knowledge of clinical research protocols and data standards
- Experience with regulatory submissions and data audits
Soft skills
- Excellent communication of complex data to diverse audiences
- Leadership and project management abilities
- Collaborative mindset with interdisciplinary teams
Educational requirements
- Master’s or PhD in biostatistics, statistics, or related field
Certifications
- SAS Certification or equivalent (preferred)
Lead Biostatistician
Position Overview
A Lead Biostatistician directs statistical operations for large-scale research projects or product pipelines. This strategic role manages statistical teams, collaborates with regulatory bodies, and ensures overall study integrity.
Lead Biostatistician Responsibilities
- Oversee all statistical aspects of clinical development programs
- Guide cross-functional teams through study design and protocol development
- Ensure alignment with international regulatory standards (FDA, EMA, ICH)
- Approve final analysis datasets and results for regulatory submission
- Lead statistical strategy discussions and influence clinical decision-making
- Train and manage junior and senior statistical staff
Lead Biostatistician Requirements
Hard skills
- Expert-level knowledge of statistical programming and methodologies
- Proven leadership in regulatory submissions and global studies
- Familiarity with CDISC, ADaM, and SDTM standards
Soft skills
- Strong leadership and team management
- Strategic decision-making and problem-solving
- Excellent communication across executive and scientific teams
Educational requirements
- PhD or master’s in biostatistics or a related discipline
Certifications
- Professional certifications in clinical research or SAS (highly preferred)
Clinical Biostatistician
Position Overview
A Clinical Biostatistician supports the design and analysis of clinical trials, contributing to drug development, medical device testing, or treatment evaluation. Their statistical insights are critical for regulatory success and clinical decision-making.
Clinical Biostatistician Responsibilities
- Design and review clinical trial protocols and statistical plans
- Analyze patient data to assess treatment safety and efficacy
- Ensure compliance with FDA and GCP regulations
- Prepare tables, listings, and figures for clinical study reports
- Collaborate with clinical operations, medical writing, and regulatory teams
Clinical Biostatistician Requirements
Hard skills
- Proficiency in SAS and knowledge of clinical trial data structures
- Understanding of regulatory frameworks and submission standards
- Experience with Phase I–IV trials
Soft skills
- Strong analytical thinking and attention to detail
- Ability to work within strict timelines and regulatory deadlines
- Clear communication of technical results
Educational requirements
- Master’s or PhD in biostatistics, statistics, or clinical research
Pharmaceutical Biostatistician
Position Overview
A Pharmaceutical Biostatistician works in drug development, applying statistical analysis to support clinical research, manufacturing processes, or real-world studies. Their work informs dosing, efficacy, and safety conclusions.
Pharmaceutical Biostatistician Responsibilities
- Provide statistical input on drug development strategies
- Support submissions to regulatory bodies like the FDA or EMA
- Analyze large-scale datasets from pharmacovigilance and trials
- Design experiments for bioequivalence and pharmacokinetic studies
- Collaborate with regulatory affairs and product development teams
Pharmaceutical Biostatistician Requirements
Hard skills
- Strong SAS or R programming skills
- Experience in pharma regulatory submissions and data audits
- Familiarity with ICH guidelines and global health authorities
Soft skills
- Problem-solving in a fast-paced R&D environment
- Collaborative skills with scientists, engineers, and marketers
- Clear, actionable statistical reporting
Educational requirements
- Master’s or PhD in biostatistics, pharmaceutical sciences, or a related field
Public Health Biostatistician
Position Overview
A Public Health Biostatistician analyzes population-level health data to inform policy, prevention strategies, and public health initiatives. This role supports government agencies, NGOs, or academic research institutions.
Public Health Biostatistician Responsibilities
- Design and analyze studies related to disease prevalence or intervention efficacy
- Work with large-scale health databases and survey data
- Develop predictive models for population health outcomes
- Collaborate with epidemiologists, health officials, and policymakers
- Communicate findings to both scientific and public audiences
Public Health Biostatistician Requirements
Hard skills
- Experience with public datasets (e.g., NHANES, BRFSS)
- Proficiency in R, Python, or Stata
- Knowledge of survey methods and public health statistics
Soft skills
- Strong communication across public and scientific channels
- Critical thinking and data-driven decision making
- Cultural competency in working with diverse populations
Educational requirements
- Master’s degree in biostatistics, epidemiology, or public health (PhD preferred)