Biostatistics Director, Medical Affairs

Role: The Biostatistics Director in Medical Affairs leads statistical activities supporting scientific communication, publications, and external collaborations for a biotech focused on rare diseases and early-stage innovative research. Responsibilities include designing and analyzing data for publications and investigator-initiated studies, developing Supplemental Statistical Analysis Plans, providing methodological guidance, and supporting real-world evidence generation. The role serves as the primary liaison between biostatistics and Medical Affairs teams, collaborating with cross-functional study groups to ensure scientific rigor and timely delivery of statistical output. Qualifications: PhD in statistics or biostatistics with 8+ years industry experience, or MS with 15+ years; expertise in post-approval or Medical Affairs settings, strong knowledge of statistical methodologies, and proven experience in scientific communication and publication support. Skills include advanced programming (R/SAS preferred), analytical problem-solving, and effective communication with technical and non-technical audiences. High-value details: Remote U.S. role with quarterly travel to San Francisco; supporting rare disease programs; involvement in real-world evidence and publication strategies; cross-functional collaboration with clinical, translational, and HEOR teams. The position emphasizes scientific rigor, innovation, and strategic support for external scientific engagement.