Senior Oncology Statistical Programmer & Lead

Ephicacy; Pennsylvania; On-site; USD 140,000 - 180,000; Full time

Job summary

Ephicacy is seeking a Principal Programmer with deep expertise in Oncology Therapeutic Areas. The role requires 10+ years of overall experience, including 5+ years in Oncology TA, and leads end-to-end programming for oncology studies and regulatory submissions in the United States.

Responsibilities include developing time-to-event analyses (Kaplan-Meier, log-rank, Cox), generating outputs compliant with FDA/EMA standards, and delivering define.xml and reviewer guides for NDA/BLA/eCTD

Qualifications

• 10+ years total experience with 5+ years in Oncology TA.
• Expert in oncology endpoints and regulatory submissions.
• Experience creating time-to-event datasets and analyses (Kaplan-Meier, log-rank, Cox).
• Lead programmer on NDA/BLA/eCTD submissions with submission-ready deliverables (define.xml, reviewer guides).
• Experience with immuno-oncology, CAR-T, or combination therapies.
• Ability to standardize and automate across studies or indications.
• Must be legally authorized to work in the United States.

Responsibilities

• Lead programming for one or more oncology studies or programs.
• Develop and maintain time-to-event analyses for oncology endpoints (PFS, OS, ORR).
• Create and validate outputs compliant with FDA/EMA requirements.
• Prepare specification documents, define.xml and reviewer guides (aSDRG/cSDRG).
• Coordinate cross-study standardization and automation efforts.

Skills

Oncology endpoints

RECIST

Kaplan-Meier

Cox models

Forest plots

Log-rank tests

Biomarker data

Genomic data

Lead programmer

Regulatory submissions

define.xml

FDA/EMA compliance

Immuno-oncology

CAR-T

End-to-end oncology

Tools

Iss/ISRE/SDRG specs

aSDRG

cSDRG

Job description

Ephicacy is seeking a Principal Programmer with deep expertise in Oncology Therapeutic Areas. The role requires 10+ years of overall experience, including 5+ years in Oncology TA, and leads end-to-end programming for oncology studies and regulatory submissions in the United States.

Responsibilities include developing time-to-event analyses (Kaplan-Meier, log-rank, Cox), generating outputs compliant with FDA/EMA standards, and delivering define.xml and reviewer guides for NDA/BLA/eCTD