Senior Director, Biostatistics
Core
Statistical leader defining and executing strategy for late-stage development programs and regulatory readiness.
Role type
Senior Director, Biostatistics (Strategic IC + Team Leadership)
Builds
Late-stage clinical programs (Phase 3) and regulatory submissions (BLA/sBLA)
Domain
Biotechnology / Pharma / Respiratory Disease
Deliverable
production ML models
Required skills
Biostatistics, Adaptive/Bayesian trial designs, Regulatory submissions, Team mentorship, Clinical trial simulations, R, SAS
Preferred skills
Respiratory disease experience, Lean biotech environment experience, Digital biomarkers, Global regulatory knowledge
Technologies
R, SAS
Responsibilities
Lead statistical strategy for late-stage programs; Draft and review SAPs and protocol statistical components; Mentor and develop a high-impact biostatistics team; Ensure high-quality execution of statistical analyses; Apply modeling and simulations to inform decision-making.
Seniority
Senior Director, Strategic Leadership & Team Management