Principal Statistical Programmer - Oncology

We are hiring for a Principal Programmer with an expert in Oncology TA.

Total experience - 10 + years with 5+ years in Oncology TA

Role requirement -

• Oncology-specific endpoints
  , like tumor response (e.g., RECIST criteria), progression-free survival, overall survival etc.
• Worked on RECIST
  , Kaplan-Meier curves, forest plots
  , Cox proportional hazards models, forest plots, log-rank tests etc., Biomarker or genomic data, if applicable
• Working and/or worked as Lead programmer on regulatory submissions (e.g., NDA, BLA, eCTD) and integrated summaries (ISS/ISE), submission-ready deliverables (e.g., define.xml, reviewer’s guides) etc.
• Created time-to-event datasets/outputs (e.g., Kaplan-Meier plots, log-rank tests, Cox models) for oncology endpoints (PFS, OS, ORR) etc.
• Experience in immuno-oncology, CAR-T, or combination therapies.
• Statistical Programming Lead (SPL) for one or more end-to-end oncology studies or programs
• Experience working on programming outputs compliant with FDA/EMA requirements.
• Generated specification, define.xml, annotated CRFs, and reviewer guides (aSDRG, cSDRG).
• Experience working on standardization and automation across studies or multiple Oncology indications

Work Authorization

Candidates must be legally authorized to work in the United States. Ephicacy is not able to provide current or future employment sponsorship for this role.