Executive Director, Statistical Programming

Position Summary:
Executive Director, Statistical Programming leads the Statistical Programming function within the Biometrics Department, providing hands-on programming and validation support, leading statistical programmers, and coordinating with vendors, statisticians, and cross-functional teams to ensure timely and accurate clinical study programming and validation (including submissions).

Responsibilities:
- Lead Statistical Programming function within Biometrics.
- Provide strategic leadership for statistical programming contributions across all clinical development projects.
- Own programming deliverables supporting analysis and reporting.
- Deliver programming/validation for clinical study reports and support programming for: analysis datasets, tables/figures/listings, ISS/ISE, DSUR, PSUR, IB, progress reports, electronic submissions, and regulatory/publication responses.
- Lead/review development of: case report forms, clinical DB specs, SAP, analysis/reporting dataset specs, validation plans, and TLFs.
- Ensure quality of all programming deliverables.
- Develop/maintain programming SOPs, work practice documents, technical standards, and specifications.
- Ensure systems/processes meet scalability, connectivity, and security requirements (with IT/QA).
- Manage/oversee vendors (contractors/CROs); conduct vendor qualifications and GCP audits (with QA).
- Identify/implement programming methodologies and develop/maintain analysis/reporting applications.
- Manage programmers and support professional development via training/coaching.
- Represent Biometrics in cross-department initiatives.

Qualifications:
- Bachelor’s degree in Statistics/CS/Math or related; Master’s preferred.
- 14+ years clinical SAS programming (Phase I–IV) in pharma/CRO; 7+ years leadership/management.

Skills/Experience:
- Strong SAS programming leadership; extensive SDTM, ADaM, Define.XML knowledge.
- Regulatory/submission understanding (CDISC/CDASH/eCTD; ICH/CHMP/FDA/GCP) and compliance experience.
- Advanced SAS (ODS, SQL, MACRO, STAT, GRAPH, ACCESS), MS Office; R is a plus.
- UNIX or Windows; strong software SDLC understanding.
- Ability to communicate effectively; travel ~10%.
- Role requires some onsite/face-to-face work in San Diego (not 100% remote).

Benefits:
- Premium health, financial/work-life/well-being offerings; wellness/support programs; life insurance, disability; retirement plan with match; generous paid time off.

Compensation:
- Target base pay range: $246,000–$332,000.

Application instructions:
- Apply on an ongoing basis until a candidate is selected.