Principal Statistical Programmer - ( Oncology )

Ephicacy; United States; On-site; USD 140,000 - 210,000; Full time

Job summary

Ephicacy is seeking a Principal Programmer with oncology therapeutic area expertise to lead statistical programming for late-stage studies. You will manage end-to-end programming and ensure regulatory deliverables meet FDA/EMA standards.

Requirements include 10+ years total experience with 5+ years in Oncology TA, proficiency in RECIST endpoints, Kaplan-Meier analyses, Cox models, and leadership on NDA/BLA/eCTD submissions. Immuno-oncology experience is a plus.

Qualifications

• Total experience 10+ years with 5+ years in Oncology TA.
• Expert in oncology endpoints (RECIST, PFS, OS).
• Experience with regulatory submissions (NDA/BLA/eCTD) and define.xml/reviewer guides.
• Created time-to-event datasets/outputs for oncology endpoints (PFS/OS/ORR).
• Experience in immuno-oncology, CAR-T, or combination therapies.

Responsibilities

• Lead programming for end-to-end oncology studies or programs.
• Ensure outputs are submission-ready and compliant with FDA/EMA.
• Standardize and automate programming across studies.
• Generate specification, define.xml, annotated CRFs and reviewer guides.

Skills

Oncology expertise

RECIST endpoints

Kaplan-Meier curves

Cox proportional hazards

Regulatory submissions

Lead programmer

Time-to-event analysis

Immuno-oncology

CAR-T

Automation

Job description

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