Principal Oncology Statistical Programmer Lead

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

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.