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 specifications
• Ensure timely delivery of all statistical deliverables for each study assigned
• Collaborate with study team members to negotiate timelines for statistical programming deliverables and related action items
• Follow departmental SOPs and processes for operational excellence
• Lead statistical programming activities for regulatory submissions following CDISC standards
• Review key study-related documents including SAP, CRFs, DTS/DTA, and data management plan
• Take ownership for the completion of SDTM and ADaM specifications for assigned studies

Qualifications

• Required: Bachelor’s degree; advanced degree (MS, PharmD, PhD) preferred
• Required: Thorough understanding of the clinical trial reporting process and regulatory reporting requirements including electronic data submissions and CDISC implementation
• Required: Thorough knowledge of SDTM/ADaM specifications and programming
• Required: Knowledge and experience complying with regulatory guidelines (FDA and international agencies)
• Required: Strong SAS programming and graphics programming skills
• Preferred: Oncology trial experience; experience with R; experience with SAS Graphics; experience with BLA/NDA/sNDA submissions to FDA/EMA or other major global health authority submissions

Skills

• Strong ability to produce in-house ADaM datasets and TFLs for CSR and other key deliverables
• Able to guide the successful completion of major programs and projects
• Strong analytical skills
• Collaborative with stakeholders across disciplines
• Proactive prioritization, adaptability, conflict resolution, and effective partnership
• Strong verbal and written communication skills
• Commitment to excellence; self-motivated, fast learner, and capable of adapting in a fast-paced environment
• Impeccable professional ethics, integrity, and judgment

Education

• Bachelor’s degree required; advanced degree (MS, PharmD, PhD) preferred

Additional Requirements

• Travel: ~10% travel anticipated