Associate Director / Director, Statistical Programming
Core
Provide technical and operational leadership for statistical programming across clinical studies, ensuring quality, accuracy, and regulatory readiness of SDTM, ADaM, and integrated analyses.
Role type
Senior IC statistical programming director (clinical data analysis)
Builds
SDTM and ADaM datasets, tables, listings, figures, define.xml, reviewer guides, integrated analyses, and regulatory submission responses
Domain
Biotechnology / Clinical Drug Development / Regulatory Submissions
Required skills
SAS programming (BASE, Macro, SQL, ODS), CDISC standards (SDTM, ADaM, define.xml), clinical study reporting, regulatory submission management, CRO/vendor oversight, data validation tools (Pinnacle 21), risk-based quality management
Preferred skills
R programming, Python, Git, metadata-driven reporting, automated QC frameworks, SOP authoring, cloud programming environments, AI-assisted programming tools
Responsibilities
Lead statistical programming for clinical studies and development programs; oversee CROs and contractors; produce and validate regulatory submission deliverables; implement scalable standards and automation; manage cross-functional partnerships and timelines
Seniority
Director, hands-on leadership
