Position Summary:
The Executive Director, Statistical Programming will lead the Statistical Programming function within the Biometrics Department, providing hands-on support for clinical study programming and validation, leading statistical programmers, and coordinating with vendors, statisticians, and internal teams to ensure timely and accurate deliverables and submissions.
Responsibilities:
- Lead the Statistical Programming function and provide strategic leadership for clinical development projects.
- Own programming deliverables supporting analysis and reporting.
- Provide programming and validation support for clinical study reports and key deliverables: analysis datasets, tables, figures, listings, ISS/ISE, DSUR, PSUR, IB, progress reports, electronic submissions, and regulatory/publication responses.
- Lead and review CRFs, clinical DB specifications, SAP, analysis/reporting datasets specs, validation plans, and TLFs.
- Ensure quality of all programming deliverables; maintain programming SOPs, standards, and specification documents.
- Ensure Biometrics systems/processes are scalable, connected, and secure (with IT/QA).
- Manage/oversight third-party providers; conduct vendor qualifications and GCP audits (with QA).
- Identify and lead programming methodologies and develop/maintain analysis and reporting applications.
- Manage programmers; train and coach Biometrics personnel.
- Represent Biometrics in cross-departmental process/quality initiatives.
Education/Experience Requirements:
- Bachelorโs in Statistics, Computer Science, Mathematics, or related technical field (Masterโs preferred).
- 14+ years of clinical SAS programming (Phase IโIV) in pharma/CRO; 7+ years in leadership/management.
Additional Skills/Experience:
- Expertise with SDTM, ADaM, Define.xml; drug development and submission/regulatory knowledge (CDISC/CDASH/eCTD; ICH/CHMP/FDA/GCP).
- SAS (ODS, SQL, MACRO, STAT, GRAPH, ACCESS) and MS Office; R is a plus.
- UNIX/Windows; strong software SDLC knowledge; strong communication.
- Travel ~10%; role is not 100% remote (on-site/face-to-face in San Diego required).
Benefits:
- Premium health, financial, work-life & well-being; wellness/support programs; life insurance, disability, retirement with employer match, and generous paid time off.
Compensation:
- Target base pay range: $246,000โ$332,000.
Application Instructions:
- Apply on an ongoing basis until the position is filled.