Senior Manager, Statistical Programming - Job ID: 1646

Role Summary

The Senior Manager, Statistical Programming provides timely and strategic programming support to clinical study teams in alignment with project goals. This role combines hands-on programming responsibilities with leadership in study execution and tool development. The successful candidate will serve as the Statistical Programming Lead for one or more clinical trials, taking responsibility for all programming deliverables from study start through regulatory submission. They will support the development and maintenance of departmental programming tools, such as standard macros and specification templates for SDTM and ADaM used across clinical studies. This position requires expertise in CDISC standards (SDTM, ADaM), strong communication and leadership skills, and a deep understanding of clinical trial data and analysis workflows. This position is based in Palo Alto, CA or may be remote.

Responsibilities

• Serve as the Statistical Programming Lead for clinical trials, overseeing all programming deliverables from study start to submission.
• Represent Statistical Programming in cross-functional study team meetings and contribute to project planning and timelines.
• Develop, validate, and maintain SDTM and ADaM datasets, following CDISC standards and study specifications.
• Generate or validate tables, listings, and figures (TLFs) for clinical study reports, ISS/ISE, and regulatory submissions.
• Support statisticians with planned and ad hoc analyses.
• Develop and maintain reusable macros, templates, and specification tools to support consistent and efficient programming practices across studies.
• Collaborate with cross-functional teams including Biostatistics, Data Management, and Medical Writing to ensure high-quality deliverables.
• Ensure programming activities meet project timelines and quality expectations, following internal SOPs and industry best practices.

Qualifications

• Bachelor’s degree in Statistics, Mathematics, Computer Science, or related field with at least 10 years of programming experience in the pharmaceutical or biotech industry; or a Master’s degree with at least 7 years of relevant experience.
• Proven experience as a lead programmer for clinical trials and complex technical projects.
• Excellent knowledge of CDISC standards, including SDTM and ADaM.
• Understanding of the clinical drug development process and regulatory requirements.
• Proficiency in SAS programming, including the ability to develop and validate reusable macros.
• Familiarity with other programming languages or tools (e.g., R, Python, Git, VB) is a plus.
• Experience contributing to departmental tools (e.g., macro libraries, specification templates, or automation tools) is preferred.
• Strong verbal and written communication skills, with the ability to collaborate effectively across functions.
• Self-motivated and detail-oriented, with the ability to manage multiple tasks and adapt to shifting priorities under tight deadlines.