Senior Statistical Programmer

Consult; United States; On-site; USD 124,000 - 193,000; Full time

Job summary

Consult is seeking a Principal Statistical Programmer with extensive Oncology experience for a senior, hands-on contract role. You will lead programming activities across late-stage studies and regulatory submissions, delivering CDISC-compliant datasets and documentation.

The ideal candidate has 10+ years in statistical programming, 5+ years in Oncology, and a proven track record with NDA/BLA submissions, time-to-event analyses, and international regulatory expectations.

Qualifications

• 10+ years of statistical programming experience
• 5+ years within Oncology
• Strong regulatory submission experience (NDA/BLA/eCTD)
• Experience producing CDISC-compliant datasets and Define.xml
• Experience with survival analyses and oncology endpoints

Responsibilities

• Lead programming activities across late-stage Oncology studies
• Oversee end-to-end programming for regulatory submissions
• Produce and review SDTM/ADaM datasets and documentation
• Collaborate with cross-functional teams to ensure submission readiness

Skills

Statistical programming

Oncology experience

Regulatory submissions

CDISC standards

Time-to-event analyses

Tools

CDISC SDTM

CDISC ADaM

Job description

I’m currently supporting a clinical-stage organisation with the search for an experienced Principal Statistical Programmer with strong Oncology experience.

This is a senior, hands-on contract opportunity for a programmer who has led programming activities across late-stage Oncology studies and regulatory submissions.

Key Requirements

• 10+ years of statistical programming experience, including 5+ years within Oncology
• Strong experience with Oncology endpoints including RECIST, ORR, PFS and OS
• Hands-on experience with Kaplan-Meier curves, Cox proportional hazards models, log-rank tests and forest plots
• Experience working with biomarker and/or genomic data
• Experience in immuno-oncology, CAR-T and/or combination therapies
• Previous experience acting as Statistical Programming Lead (SPL) for end-to-end Oncology studies or programmes
• Strong regulatory submission experience, including NDA, BLA, eCTD, ISS/ISE and submission-ready deliverables
• Experience producing and reviewing CDISC-compliant datasets and documentation, including SDTM, ADaM, Define.xml, annotated CRFs and reviewer guides (aSDRG/cSDRG)
• Experience developing time-to-event datasets and outputs for Oncology endpoints
• Strong understanding of FDA and EMA requirements for statistical programming and regulatory submissions
• Experience with standardisation and automation across studies and/or multiple oncology indications