Senior Director of Biostatistics

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 Experience: 14 years required