Manager, Statistical Programming

Gilead Sciences seeks a Manager in Statistical Programming to lead the development of analysis datasets and statistical outputs for clinical studies. The role involves collaborating with clinical development teams to deliver high-quality programming outputs that support regulatory submissions and integrated analyses.

Responsibilities

• Collaborate with Clinical Development staff to deliver statistical analyses and reports on schedule
• Generate or oversee production of programming deliverables including tables, figures, and listings for study reports
• Ensure programming documentation meets departmental procedures and regulatory standards
• Create user-defined statistical reports and resolve study-related issues across therapeutic projects
• Implement strategic initiatives and negotiate timelines with stakeholders

Requirements

• BS in Biostatistics/Computer Science plus 7+ years pharma/biotech experience, or MS plus 3+ years, or PhD plus 2+ years
• Advanced knowledge of statistics and analytical skills
• Thorough understanding of clinical trial design, regulatory reporting, and FDA/PMDA/EMA submission requirements
• Extensive SAS experience including macro development
• Advanced knowledge of CDISC standards (CDASH, SDTM, ADaM)
• Experience with pivotal studies and regulatory submissions (NDA, BLA, MAA)
• Strong interpersonal and written communication skills

Compensation: $146,540–$189,640 base