Executive Director, Statistical Programming

Role: Executive Director, Statistical Programming leading the Biometrics Department, responsible for overseeing statistical programming activities across clinical development projects. Objectives include ensuring timely, high-quality deliverables such as analysis datasets, tables, listings, and regulatory submissions, while managing programming standards and vendor relationships. Responsibilities encompass providing strategic leadership, managing or overseeing external vendors and CROs, developing and maintaining SOPs and technical standards, and supporting submission activities with expertise in SDTM, ADaM, and regulatory guidelines. Qualifications: Bachelor's in Statistics, Computer Science, Mathematics, or related field; 14+ years in SAS programming within clinical trials (Phase I-IV), with at least 7 years in leadership roles. Skills required include advanced SAS (ODS, SQL, MACRO), knowledge of SDTM, ADaM, eCTD, and regulatory compliance, along with vendor management and team mentorship experience. Preferred: Master's degree, familiarity with R, UNIX, and Windows OS. High-Value: Leadership in a global biopharmaceutical environment supporting rare disease programs; experience with submission support and GxP standards; ability to travel (~10% domestically and internationally). Work setup: Remote-based with on-site requirements in San Diego.