Senior Statistical Programmer Lead – Oncology Trials

Revolution Medicines, Inc.; San Francisco (CA); On-site; USD 164,000 - 205,000; Full time

Job summary

Revolution Medicines in San Francisco, CA seeks a Senior Statistical Programmer to lead programming activities for oncology programs and oversee contractors/CROs. You will ensure CDISC compliance and support regulatory submissions.

The role emphasizes mentorship, timely analysis delivery, and adherence to SOPs and GxP, with a focus on enabling high-quality trial results for FDA and other authorities.

Qualifications

• 10-14 years of Statistical Programming experience in biotechnology or pharmaceutical industry.
• BS/BA degree or other suitable qualification with relevance to the field.
• Direct statistical programming experience for early or late-phase clinical trials to support production/verification of analysis datasets, tables, listings, and figures.
• Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team.

Responsibilities

• Provide technical oversight of statistical programming resources including contractors and CROs.
• Provide mentorship to future leaders to help learn and execute on RevMed core values.
• Ensure quality and timely delivery of analysis for statistical programming deliverables.
• Provide solutions by analyzing issues and problems in complex situations.
• Ensure accuracy of clinical trial results for internal and external audiences via QC of documents with clinical data.
• Ensure that the statistical programming process conforms to the SOPs and regulatory standards where applicable.
• Timeline and vendor management for deliverables, including submission-related activities, complying with regulatory standards (e.g., FDA 21 CFR Part 11, GxP).
• Programming support for deliverables, such as Dose Committee meetings, Investigator Brochures, publications/presentations, US, and ex-US regulatory submissions.
• Proficiency in regulatory standards and compliance regulations including CDISC compliance (SDTM, ADaM, define.xml, Reviewer's Guides, etc.).

Skills

Statistical programming

Leadership

CDISC SDTM/ADaM

Regulatory submissions

Mentoring

Vendor management

GxP compliance

Problem solving

Education

BS/BA degree or relevant field

Job description

Revolution Medicines in San Francisco, CA seeks a Senior Statistical Programmer to lead programming activities for oncology programs and oversee contractors/CROs. You will ensure CDISC compliance and support regulatory submissions.

The role emphasizes mentorship, timely analysis delivery, and adherence to SOPs and GxP, with a focus on enabling high-quality trial results for FDA and other authorities.