Executive Director, Statistical Programming

Role: Senior strategic leader overseeing statistical programming for late-stage biotech development programs, primarily supporting clinical trials and regulatory submissions. Responsibilities: provide leadership in programming strategy, ensure quality and compliance of analysis deliverables, develop scalable standards, manage vendor relationships, and collaborate with cross-functional teams including Biostatistics, Data Management, Clinical Development, and Regulatory Affairs. Requirements: B.S. in a quantitative field; 17+ years in statistical programming or biometrics, including leadership, with extensive regulatory submission experience (e.g., BLA/IND). Preferred: advanced degree, experience in ophthalmology or biologics/gene therapy, and proficiency in SAS, R, and standards like CDISC, SDTM, ADaM. High-value specifics: focus on late-stage development, regulatory submission leadership, GxP and regulatory compliance, and cross-functional coordination in a fast-paced environment. Work setup: travel <5%, with physical activity limited to sedentary work.