Executive Director, Statistical Programming

Role: Executive Director, Statistical Programming leading the Biometrics department within a biopharmaceutical company focused on rare diseases. Responsibilities: oversee statistical programming activities across clinical development, ensure quality and timely delivery of analysis datasets, tables, figures, listings, and regulatory submissions; manage external vendor relationships, develop programming standards and SOPs, and contribute to system improvements. Provide strategic leadership and direct support for submissions and clinical reports, while mentoring programming staff. Requirements: Bachelor's degree in Statistics, Computer Science, Mathematics, or related; 14+ years of SAS programming experience in Phase I-IV trials, with at least 7 years in leadership roles; expertise in SDTM, ADaM, ICH GCP, CDISC standards, and regulatory submission processes. HighValue: biologics or small molecules in rare disease space, clinical trial phases I-IV, submission support, GxP compliance, SAS, UNIX/Windows systems, vendor management, and international travel (~10%). WorkSetup: Remote in San Diego with face-to-face and travel requirements.