Principal Biostatistician Jobs
Principal Biostatistician jobs are open across pharmaceutical, biotech, medical device, and clinical research organizations, from senior statistician to director level, with specializations in clinical trials, regulatory submissions, and real-world evidence. Find a role that fits below and apply directly.
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Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need. Precigen is dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies utilizing the company’s AdenoVerse® and UltraCAR-T® therapeutic platforms across its core focus areas of immuno-oncology, autoimmune disorders, and infectious diseases.
POSITION SUMMARY:
The Principal Biostatistician is the sponsor's statistical lead for all company-sponsored studies and evidence-generation activities across Clinical Development and Medical Affairs. Statistical programming and analysis are outsourced; this role owns the statistical science, from study design through interpretation, and holds CRO statistics and programming teams to sponsor standards. The role is a scientific partner to Clinical Development, Medical Affairs and Regulatory.
DUTIES AND RESPONSIBILITIES:
- Author or approve statistical sections of protocols and amendments: objectives, estimands (ICH E9(R1)), endpoints, sample size and randomization.
- Author or approve statistical analysis plans and TLF shells; ensure analysis is aligned to the scientific and regulatory question.
- Advise on endpoint selection, adaptive and interim designs, and multiplicity strategy.
- Oversee CRO biostatistics and programming: SDTM/ADaM specifications, define.xml, validation approach, TLF review and delivery timelines.
- Contribute to statistical and programming vendor selection and scope; review change orders for statistical work.
- Support data monitoring committees and interim analyses, including firewalls and unblinding controls.
- Interpret and present results; co-author CSRs and statistical sections of regulatory documents, briefing books and responses to agency questions.
- Design analysis approaches for Phase 3b/4, registry, real-world and chart review studies, including observational methods (e.g. propensity score methods, handling of missing data and bias).
- Support publications, congress abstracts, post-hoc and exploratory analyses with appropriate statistical rigor.
- Set portfolio statistical standards and SAP templates; partner with the Clinical Data Manager on data standards and lock readiness.
- Provide statistical input to development plans, evidence-generation plans and business development due diligence.
- Other duties as assigned.
EDUCATION AND EXPERIENCE:
- PhD in biostatistics or statistics with 10+ years or MS with 14+ years.
- Experience across clinical development phases; registrational study or submission experience strongly preferred.
- Experience overseeing CRO statistics and programming; working knowledge of SAS and/or R and CDISC SDTM/ADaM.
- Knowledge of ICH E9 and E9(R1), FDA and EMA statistical guidance; real-world evidence or observational methods experience valued.
- Clear communicator with non-statisticians, including executives and regulators.
DESIRED KEY COMPETENCIES:
- Self-organizer, highly motivated, and keen attention to detail.
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
- Ability to understand and execute the company’s mission and values.
- Maintain a high degree of ethical standard and trustworthiness.
- Exhibits an open mindset when approaching challenges and conflict.
- Ability to think and adapt to a rapidly changing environment and demands.
- Strong time management and organizational skills.
- Ability to manage multiple projects in a fast-paced environment.
Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need. Precigen is dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies utilizing the company’s AdenoVerse® and UltraCAR-T® therapeutic platforms across its core focus areas of immuno-oncology, autoimmune disorders, and infectious diseases.
POSITION SUMMARY:
The Principal Biostatistician is the sponsor's statistical lead for all company-sponsored studies and evidence-generation activities across Clinical Development and Medical Affairs. Statistical programming and analysis are outsourced; this role owns the statistical science, from study design through interpretation, and holds CRO statistics and programming teams to sponsor standards. The role is a scientific partner to Clinical Development, Medical Affairs and Regulatory.
DUTIES AND RESPONSIBILITIES:
- Author or approve statistical sections of protocols and amendments: objectives, estimands (ICH E9(R1)), endpoints, sample size and randomization.
- Author or approve statistical analysis plans and TLF shells; ensure analysis is aligned to the scientific and regulatory question.
- Advise on endpoint selection, adaptive and interim designs, and multiplicity strategy.
- Oversee CRO biostatistics and programming: SDTM/ADaM specifications, define.xml, validation approach, TLF review and delivery timelines.
- Contribute to statistical and programming vendor selection and scope; review change orders for statistical work.
- Support data monitoring committees and interim analyses, including firewalls and unblinding controls.
- Interpret and present results; co-author CSRs and statistical sections of regulatory documents, briefing books and responses to agency questions.
- Design analysis approaches for Phase 3b/4, registry, real-world and chart review studies, including observational methods (e.g. propensity score methods, handling of missing data and bias).
- Support publications, congress abstracts, post-hoc and exploratory analyses with appropriate statistical rigor.
- Set portfolio statistical standards and SAP templates; partner with the Clinical Data Manager on data standards and lock readiness.
- Provide statistical input to development plans, evidence-generation plans and business development due diligence.
- Other duties as assigned.
EDUCATION AND EXPERIENCE:
- PhD in biostatistics or statistics with 10+ years or MS with 14+ years.
- Experience across clinical development phases; registrational study or submission experience strongly preferred.
- Experience overseeing CRO statistics and programming; working knowledge of SAS and/or R and CDISC SDTM/ADaM.
- Knowledge of ICH E9 and E9(R1), FDA and EMA statistical guidance; real-world evidence or observational methods experience valued.
- Clear communicator with non-statisticians, including executives and regulators.
DESIRED KEY COMPETENCIES:
- Self-organizer, highly motivated, and keen attention to detail.
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
- Ability to understand and execute the company’s mission and values.
- Maintain a high degree of ethical standard and trustworthiness.
- Exhibits an open mindset when approaching challenges and conflict.
- Ability to think and adapt to a rapidly changing environment and demands.
- Strong time management and organizational skills.
- Ability to manage multiple projects in a fast-paced environment.
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Find JobsPrincipal Biostatistician Job Market
Who's Hiring
Top Industries Hiring
- Science & Research
What Employers Look For
The qualifications that appear most often in principal biostatistician jobs.
- Advanced degree in biostatistics or statistics with five or more years of clinical trial experience
- Expert-level SAS or R programming in a validated, GxP-compliant environment
- Independent authorship of statistical analysis plans for Phase II or Phase III trials
- Working knowledge of FDA, EMA, or ICH E9 and E9(R1) guidelines for clinical submissions
- Experience contributing to regulatory submissions including NDA, BLA, or IND packages
- Proficiency with CDISC standards including SDTM and ADaM data structures
Tips for Your Principal Biostatistician Job Search
Tailor your resume to therapeutic area
Hiring managers for principal biostatistician roles often filter by oncology, cardiovascular, or rare disease experience before looking at methods. Lead each resume bullet with the therapeutic area, then the statistical method, so your fit is obvious at a glance.
Show regulatory submission experience explicitly
Many listings require hands-on NDA, BLA, or IND submission experience, not just familiarity with guidelines. Name the submission type, your role in it, and the phase in your resume so reviewers don't have to infer it from job titles alone.
Apply early to roles that fit
Migrate Mate lists principal biostatistician openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Highlight programming language depth, not breadth
Job postings for principal biostatisticians consistently distinguish between SAS-primary and R-primary environments. Match the language stack in the listing precisely, and name production-level macros, packages, or validated environment experience rather than listing every tool you've touched.
Prepare a statistical section plan for the interview
Many principal biostatistician interviews ask you to walk through how you would design or analyze a specific study. Preparing a one-page statistical section plan for a Phase III oncology or cardiovascular trial gives you a concrete artifact to discuss and shows you can operate independently at that level.
Negotiate scope before title during offer discussions
At the principal level, two offers with identical titles can differ dramatically in trial ownership, FDA-interaction responsibility, and team leadership. Ask specifically which studies you would lead independently and whether the role carries first-author responsibility on SAPs before comparing compensation.
Principal Biostatistician Jobs: Frequently Asked Questions
Which companies are hiring the most principal biostatisticians?
Thermo Fisher Scientific, IQVIA, and Cordis are hiring the most principal biostatisticians right now, with openings concentrated in California, North Carolina, and Maryland, based on current listings on Migrate Mate as of November 2026. Contract research organizations and large biopharma sponsors tend to post the highest volume of openings at this level.
How many principal biostatistician jobs are remote?
About 80% of principal biostatistician openings are fully remote or hybrid as of November 2026, reflecting how thoroughly the role shifted during the shift to distributed clinical trial operations. Roles focused on late-phase regulatory submissions and real-world evidence analysis tend to have the highest share of fully remote arrangements, while positions tied to on-site data review committees or biomarker labs are more likely to require in-person presence.
How do you become a principal biostatistician?
Most principal biostatisticians start with a master's or doctoral degree in biostatistics or statistics, then build several years of experience as a biostatistician or senior biostatistician on clinical trials. The step up to principal typically requires independent statistical analysis plan authorship, demonstrated regulatory submission experience, and the ability to advise study teams on design and analysis strategy without day-to-day supervision.
Can you get a principal biostatistician job without direct clinical trial experience?
It's difficult but not impossible. Candidates from academic research, epidemiology, or government health agencies who have deep applied statistics experience sometimes transition by targeting contract research organizations that offer on-the-job regulatory training. The most effective approach is to emphasize longitudinal data analysis, survival models, or missing data methods, since those skills transfer directly to Phase II and Phase III trial work and appear in most principal-level job requirements.
What does the principal biostatistician interview process look like?
The process typically runs three to four rounds. An initial call with a recruiter or HR contact is followed by a technical screening with a senior statistician or biostatistics director, where you can expect questions on estimands, adaptive designs, and regulatory precedent. A panel interview with clinical development or medical affairs colleagues assesses cross-functional communication. Some employers conclude with a written or verbal case study asking you to outline an analysis strategy for a hypothetical trial.
Where can I find and apply to principal biostatistician jobs?
You can find and apply to principal biostatistician jobs on Migrate Mate, which lists current openings from companies across the United States. Search the listings to find roles that match your therapeutic area and methods experience, then apply directly to each one that fits.
See All 12 Principal Biostatistician Jobs
Find roles that match your experience and apply in just a few clicks.
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