Senior Director, Biostatistics

Formation Bio seeks a highly skilled and experienced Senior Director to oversee statistical strategy in clinical drug development. The role reports to the Head of Biometrics.

Key Responsibilities

• Leadership: Build and mentor the biostatistics team while fostering alignment with company values
• Strategic Direction: Implement innovative trial designs, Bayesian methods, and AI/ML approaches across development programs
• Study Design: Provide statistical expertise for clinical studies, endpoint selection, and regulatory submissions
• Regulatory Affairs: Represent the function in FDA/EMA interactions and briefing materials
• Operations: Establish workflows, standard operating procedures, and quality controls
• Decision-Making: Champion data-driven frameworks including scenario analyses and trial simulations
• Vendor Management: Oversee CRO and statistical consultant relationships
• Industry Engagement: Stay current on regulatory trends and represent the company externally

Requirements

• Ph.D. in Biostatistics, Statistics, or related field
• 10+ years pharma/biotech industry experience
• Proven team leadership in clinical development
• Expertise in adaptive designs, Bayesian methods, simulation approaches
• FDA/EMA regulatory knowledge
• Quantitative decision-making experience
• Proficiency in SAS, R programming, and statistical software (East, PASS, NQuery)
• Cross-functional collaboration ability
• Strong communication skills for technical and non-technical audiences