Director of Statistical Programming

Role: Director of Statistical Programming leading activities across multiple clinical studies, focusing on timely, high-quality deliverables and regulatory submissions. Responsibilities include managing and validating CRO outputs, overseeing study reporting and data integration, establishing programming infrastructure, driving automation with AI tools, and setting standards and SOPs. The position entails cross-functional collaboration, representing the programming function in study teams, and ensuring compliance with industry standards.

Qualifications: MS in Statistics, Computer Science, or related field with 10+ years (or BS with 12+ years) of relevant experience; at least 5 years in a lead statistical programming role. Deep knowledge of CDISC standards, FDA SDTCG, and experience in NDA/BLA submission. Preferred experience includes CRO oversight, integrating AI into data workflows, and working within biopharma development stages.

High-Value Details: Remote U.S.-based role with biannual visits to San Francisco; involves working in a fast-paced environment on multiple projects. Focus on clinical programming for drug development, with an emphasis on regulatory compliance, automation, and innovative data management practices.