Manager, Statistical Programming

Gilead Sciences · Foster City, CA

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BiometricsFull-time$147k–$190kCompany career page

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Role summary

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.

What they're looking for

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

What you'll be doing

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

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