Lead Oncology Statistical Programmer for Regulatory Submissions

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

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.