Principal Statistical Programmer - Oncology

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

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.