Director of Statistical Programming

Role overview A director-level statistical programming role leading programming activities across multiple clinical studies, including hands-on programming and oversight of CRO deliverables. The position supports regulatory submissions and helps advance programming standards, automation, and AI-assisted tooling within a biopharma organization focused on rare disease drug development.

Responsibilities - Lead statistical programming for several clinical studies, ensuring deliverables meet timelines, quality, and cross-study consistency - Review and validate CRO outputs against CDISC standards and study requirements - Manage or directly execute deliverables tied to study monitoring, clinical study reports, data integrations, and regulatory query responses - Coordinate programming work with external partners and cross-functional study teams - Build and maintain the SAS reporting environment, infrastructure, and utility macros; champion modern methods, including AI-assisted tools, to improve efficiency and compliance - Develop, document, and uphold programming standards, processes, and SOPs

Requirements - MS in Statistics, Computer Science, or a related field with 10+ years of relevant experience, or BS with 12+ years; at least 5 years as a lead statistical programmer - Extensive knowledge of CDISC standards and FDA submission data tabulation guidance - Hands-on SAS programming experience with clinical development datasets - Experience supporting NDA/BLA submissions and biostatistics regulatory compliance - Demonstrated ability to manage multiple projects in a fast-paced environment

Nice to have - Prior CRO oversight experience - Integrating AI tools into clinical data pipelines and statistical workflows

Benefits and work setup - Remote U.S.-based role with occasional in-person visits (a few times per year) to a San Francisco office - Market-competitive compensation including base pay, annual performance bonus, and equity - 401(k) with employer match, employee stock purchase program, and pre-tax commuter benefits - Comprehensive medical, dental, and vision coverage for employees and dependents, plus HSA contributions and FSA options - Fertility and family-forming benefits, expanded mental health support, flexible paid time off, paid holidays, and paid medical and parental leave - Career development resources including online learning platforms and coaching programs