Biostatistics Director, Medical Affairs

Role overview This director-level biostatistics role sits within Medical Affairs at a rare-disease biopharma organization, leading statistical and programming work for external scientific communications. The position partners with Medical Affairs, Clinical Biostatistics, and Statistical Programming to shape publication strategy, drive supplemental analysis plans, and support real-world evidence generation. It is built for a senior biostatistician who thrives at the intersection of methodology, publications, and cross-functional science.

Responsibilities - Lead statistical and programming efforts for medical publications, congresses, and external collaborations. - Guide statistical design and analysis for investigator-initiated research and collaborative studies. - Develop and maintain Supplemental Statistical Analysis Plans. - Provide methodological guidance and brainstorm scientifically sound approaches with Medical Affairs partners. - Plan publication strategies for upcoming congresses and manuscript generation. - Generate exploratory and ad hoc analyses to surface insights and evidence-generation opportunities. - Support HEOR and real-world evidence requests as needed.

Requirements - PhD in statistics or biostatistics with 8+ years of pharma or biotech experience, or MS with 15+ years of equivalent experience. - Experience operating in Medical Affairs or post-approval biostatistics settings. - Strong command of statistical methodologies, drug development trends, and regulatory environments. - Established publication record supporting scientific communication. - Excellent communication skills with both technical and non-technical audiences. - Strong programming skills with R or SAS, able to produce publication-ready figures independently.

Benefits and work setup - US-based remote role with quarterly or as-needed visits to a San Francisco office. - Anticipated California-based salary range of USD $222,300 to $255,000, plus annual bonus and equity. - 401(k) with employer match, ESPP, and pre-tax commuter benefits. - 100% employer-paid medical, dental, and vision coverage for employees and dependents, plus HSA, FSA, fertility, and mental health benefits. - Flexible paid time off, paid holidays, and comprehensive medical and parental leave. - Learning programs through LinkedIn Learning, LifeLabs, and coaching, with internal mobility opportunities.