Sr Principal Analyst, Statistical Programming

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.

• 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 processes, standards, and efficiencies, and help drive adoption of best practices across teams.
• Ensure consistency and compliance with data, analysis, CDISC, and regulatory submission standards across studies and programs.

• You love analytics and are passionate about using data to drive key business decisions.
• You love learning new technological skills and working through collaboration.

• Bachelor's degree required;
  Master's or PhD in Statistics, Mathematics, Biostatistics, or a related quantitative field preferred.
• 10+ years of pharmaceutical, biotechnology, or CRO industry experience with a focus on clinical data analysis and statistical programming.
• 10+ years of hands-on SAS programming experience, including extensive use of Base SAS; 7+ years utilizing SAS STAT, SAS Macro, and SAS Graph.
• 10+ years of experience supporting clinical trials across multiple phases of drug development.
• 5+ years of experience working with clinical databases and clinical data structures.
• Demonstrated expertise in CDISC standards (SDTM and ADaM) and regulatory submission deliverables.
• Strong understanding of the drug development lifecycle, clinical trial processes, and industry best practices.
• In-depth knowledge of global regulatory submission requirements, including ICH guidelines and FDA, EMA, and other international health authority standards.
• Working knowledge of UNIX/Linux environments.
• Proven leadership experience with the ability to effectively manage projects, oversee vendors, and collaborate across cross-functional teams.
• Exceptional attention to detail, organizational skills, and the ability to prioritize and manage multiple concurrent initiatives in a fast-paced environment.

• Experience with ISS/ISE development and NDA/BLA submissions
• Proficiency in R programming
• Experience working in a global regulatory environment

While this position is ideally based in the Bay Area (San Francisco, CA), we are open to considering remote candidates with the right experience and qualifications.

Job Level: Management

The base compensation range for this role is: $-$

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills &…