Assoc Director, Statistical Programming

Role: Associate Director of Statistical Programming, supporting Gilead's clinical trial analysis and regulatory submissions. Responsibilities: collaborate with Clinical Development to deliver analysis datasets and reports, oversee programming tasks for study reports and integrated summaries, ensure compliance with regulatory standards (FDA, PMDA), and lead strategic initiatives within the programming team. Requirements: BS in Biostatistics/Computer Science with 10+ years, MS with 8+ years, or PhD with 3+ years in pharma/biotech; extensive SAS programming expertise, especially in regulatory submissions and CDISC standards; strong understanding of clinical trial design, GxP, and global regulatory requirements; experience in oncology, hematology, virology, or inflammation preferred. High-value: senior-level biostatistics and programming experience, regulatory submission involvement, familiarity with pivotal studies, and expertise in fast-paced development environments. Work setup: hybrid positions in Foster City, CA or Raleigh, NC.