Senior Statistical Programmer

Role Summary

Senior Statistical Programmer reporting to the Principal Statistical Programmer, accountable for all assigned statistical programming deliverables in adherence to company SOPs and ICH/GCP. Opportunity to work on late phase trials and contribute to patient care in breast cancer. Based in San Francisco with approximately 10% travel.

Responsibilities

• Conduct hands-on validation/QC of CRO deliverables to ensure high-quality SDTMs, ADaMs, and TFLs, and ensure accuracy of clinical trial results for internal and external audiences
• Conduct hands-on programming of deliverables including IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, and Safety Detection
• Ensure all relevant deliverables (investigator brochures, publications, all regulatory submissions with SDTM/ADaM compliance, supporting documentation such as define.xml, reviewer’s guide, and annotated CRFs) conform to SOPs and regulatory speci...