Senior Director of Biostatistics

Job Summary

As a hands-on leader in a full-time remote position, the Senior Director of Biostatistics will manage statistical strategy for a growing portfolio, lead the biostatistics team, and serve as the primary statistical interface with regulators while overseeing active clinical programs from protocol development through regulatory submission.

Key responsibilities

• Set statistical strategy and lead the biostatistics, statistical programming, and medical writing functions
• Personally lead statistics on active programs, including protocol development and clinical study reports
• Serve as the primary statistical voice with regulators, authoring and reviewing submissions and responding to queries

Required qualifications

• PhD in statistics or biostatistics with 10+ years of relevant experience, or MS with 15+ years, including lead statistician experience
• Experience interacting with health authorities on early-phase programs, with adaptive trial design experience required
• Strong knowledge of CDISC standards, regulatory submission requirements, and current drug development trends
• Excellent programming skills, preferably in R and/or SAS, with familiarity in AI/ML tools for statistical workflows
• Proven track record of hiring and developing statisticians, ideally in building or scaling a biostatistics function