Director Biostatistics

A rapidly growing, science‑driven biotech is seeking a Director of Biostatistics to provide strategic and technical leadership across large, complex late‑phase clinical programs. This is a high‑visibility role supporting global development, regulatory submissions, and innovative clinical trial design in a cutting‑edge therapeutic area.

Key Responsibilities:

• Drive statistical strategy for late‑phase clinical development programs, including innovative trial design and endpoint strategy.
• Author statistical sections of protocols and lead development of SAPs for Phase 2/3 studies and integrated analyses.
• Partner cross‑functionally with Clinical Development, Regulatory, Data Management, and Clinical Operations.
• Provide statistical oversight for randomization, stratification, eCRF design, and ongoing trial conduct.
• Collaborate with programming teams on ADaM specifications, analysis outputs, and data interpretation.
• Lead statistical contributions to global regulatory submissions, briefing documents, and responses to agency questions.
• Represent the biometrics function in internal and external meetings, including with investigators and scientific partners.
• Contribute to publications, manuscripts, and scientific presentations.

Required Qualifications:

• PhD in Statistics/Biostatistics (or other relevant field) with 7+ years of pharmaceutical/biotech experience.
• Strong background in late‑phase clinical trials, including design, analysis, and regulatory deliverables.
• Experience with clinical trial simulations to evaluate design options and operating characteristics.
• Extensive knowledge and experience with Bayesian and adaptive design approaches.
• Proficiency in SAS and R; comfort working with advanced analytical methods.
• Experience supporting regulatory submissions.
• Excellent communication skills and the ability to translate complex statistical concepts for diverse audiences.
• Collaborative mindset and ability to lead within a matrixed, fast‑moving environment.