Assoc Director, Statistical Programming

Gilead Sciences seeks an Associate Director of Statistical Programming to lead the production of analysis datasets and statistical outputs for clinical study reports and regulatory submissions. This hybrid role in Foster City, CA or Raleigh, NC requires extensive pharma experience and expertise in clinical trial programming and FDA submission processes.

Responsibilities

• Collaborate with Clinical Development to deliver statistical analysis and reporting projects on schedule
• Generate or oversee production of programming deliverables including tables and listings for study reports
• Direct design and coding of analysis files while ensuring compliance with departmental procedures and documentation standards
• Lead strategic initiatives and process improvements across therapeutic areas while providing primary and secondary programming support
• Interact with cross-functional departments to define, produce, and deliver ad hoc statistical reports and user-defined analyses

Requirements

• BS in Biostatistics/Computer Science plus 10+ years pharma/biotech experience, OR MS plus 8+ years, OR PhD plus 3+ years
• Thorough understanding of clinical trial design, regulatory reporting requirements, and FDA/PMDA submission processes
• Extensive hands-on experience with regulatory submissions, integrated analysis, and post-submission activities
• Proficiency with SAS software including macro development and advanced CDISC standards (CDASH, SDTM, ADaM)
• Proven ability to manage complex, time-sensitive tasks and resolve study-related issues independently
• Strong verbal and written communication skills with demonstrated ability to influence stakeholders and negotiate timelines

Compensation: Bay Area: $195,670–$253,220; Raleigh: $168,980–$218,680 base