Sr Principal Analyst, Statistical Programming
Full-time
US
Oct 29, 2026
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About the Role
About This Role The Senior Principal Analyst, Statistical Programming reports to the Head of Statistical Programming, West Coast Hub, and provides leadership and oversight of statistical programming activities across internal teams and external vendors at both the study and program levels. This role ensures the timely delivery of high-quality programming outputs in compliance with company SOPs, ICH/GCP guidelines, and regulatory requirements, while driving the implementation of data strategy initiatives and standardized programming practices across studies and development programs. What You’ll Do Lead and oversee statistical programming activities across studies or programs, including coordinating internal teams and external vendors to ensure timely, high-quality deliverables. Serve as the Statistical Programming Lead for one or more clinical programs, driving key milestones, managing priorities, and addressing resource or project challenges. Manage programming deliverables from database build through regulatory submission, including experience with eSub components such as define.xml, annotated CRFs, reviewer guides, and transport files. Partner with cross-functional stakeholders to communicate programming requirements, project status, risks, and resource needs. Develop ADaM specifications, support statistical analyses, and collaborate with Biostatistics to define and implement endpoint derivations and analysis algorithms. Identify opportunities to improve programming process