Executive Director, Head of Biostatistics
$274,000–$363,000 year
On-sitePrinceton, New Jersey, United States
Job Summary
Shape clinical development strategy by influencing study design, endpoint selection, estimand frameworks, and key decisions from protocol concept through NDA submission. Lead regulatory statistical strategy as the primary statistical representative in FDA interactions, including briefing packages, meetings, and submission support. Provide expert leadership in innovative methodologies such as precision medicine approaches, adaptive designs, and Bayesian methods. Serve as a trusted strategic partner to Clinical Development, Medical, Regulatory Affairs, and executive leadership on program strategy and statistical risk. Build and develop a high-performing Biostatistics organization while establishing governance and quality systems for regulatory compliance. Oversee external statistical partners and CROs to maintain scientific ownership and accountability for all deliverables. Partner across the Biometrics organization to strengthen evidence generation and support business development and due diligence activities.
Required Qualifications
- Ph.D. in Biostatistics, Statistics, or a closely related quantitative discipline
- 15+ years of experience in pharmaceutical or biotechnology drug development, with substantial late-phase program experience
- Demonstrated experience as the statistical lead or signatory on at least one NDA or BLA submission; must have been in the room, not only in a supporting role
- Direct FDA interaction experience, including Type B or C meetings, statistical briefing documents, and responses to regulatory queries
- Deep expertise in late-phase statistical methodology, including estimand frameworks, adaptive designs, surrogate endpoint validation, precision medicine and responder subgroup analysis, and multiplicity control
- Bayesian methodology proficiency, including prior elicitation, posterior decision frameworks, and simulation-based design evaluation
- Demonstrated ability to influence cross-functional leadership and program decisions through scientific expertise, credibility, and clarity of judgment
- Proven track record of developing and elevating statistical talent in a team environment
- Excellent verbal and written communication skills, with the ability to translate complex statistical concepts for technical, clinical, medical, regulatory, and executive audiences
- Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required
Desired Qualifications
- Cardiovascular or cardiometabolic clinical development experience
- Experience with precision medicine frameworks, biomarker-driven trial design, and responder subgroup methodology in a regulatory submission context
- Strong epidemiology or real-world data fluency, including observational study methodology and defining or refining target patient populations for precision-medicine-driven trials
- Familiarity with digital health endpoints and novel data sources, including wearables or continuous monitoring approaches
- External scientific presence through publications, conference presentations, professional society involvement, or KOL relationships in the cardiovascular or biostatistics community
- Prior experience working in a small, fast-paced, high-growth biotechnology company
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