Senior Director, Biostatistics

Role Summary

Senior Director of Biostatistics, reporting to the VP of Biostatistics, you will lead the statistical strategy and execution of a pivotal Phase 3 clinical trial and all associated NDA activities. You will apply and share knowledge of appropriate statistical methods for clinical trial design and data analysis, and collaborate cross-functionally to support planning, execution, and analysis of the trial. This role is based in either San Francisco, CA or Cambridge, MA, with minimal travel.

Responsibilities

• Lead the biostatistics strategy and execution for a pivotal Phase 3 trial and ISS/ISE, ensuring scientific rigor and global regulatory alignment.
• Apply innovative statistical methods to optimize study design, analysis strategies, and data interpretation.
• Develop and author key statistical documents.
• Lead statistical activities for regulatory submissions and prepare briefing materials for health authority i...