Senior Statistical Programmer – Oncology Trials

RBW Consulting; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

RBW Consulting is seeking a Principal / Senior Statistical Programmer to support Phase I-III clinical development. The role focuses on creating analysis datasets, SAEs, and regulatory submission outputs, while partnering with Biostatistics, Data Management, and external vendors.

The candidate should have 5+ years of statistical programming experience in biotech/pharma (oncology preferred), with strong ADaM/TLFs, CDISC, define.xml, and Pinnacle 21 expertise.

Qualifications

• 5+ years of statistical programming experience in biotech/pharma, oncology preferred.
• Experience creating ADaM datasets, TLFs, and regulatory submission deliverables.
• Strong knowledge of CDISC standards, define.xml, and FDA/EMA submission requirements.
• Experience with Pinnacle 21 and regulatory filing packages.
• Exposure to R and/or Python.
• Interest in automation and AI-enabled programming solutions.

Responsibilities

• Lead statistical programming activities across clinical studies with high-quality, timely deliverables.
• Develop and validate ADaM datasets, TLFs, define.xml, reviewer guides, and submission outputs.
• Support regulatory submissions to FDA/EMA and other health authorities.
• Collaborate with Biostatistics to implement analysis plans and study reporting requirements.
• Support data review, cleaning, database lock activities, and vendor data reconciliation.
• Contribute to programming standards, automation initiatives, and process improvements.
• Mentor junior programmers and provide technical guidance.

Skills

Statistical programming

Automation

Regulatory submissions

Mentoring

R & Python

ADaM/TLFs/define.xml

Education

BS/MS in Statistics/Biostatistics/CS/Mathematics

Tools

Pinnacle 21

Job description

RBW Consulting is seeking a Principal / Senior Statistical Programmer to support Phase I-III clinical development. The role focuses on creating analysis datasets, SAEs, and regulatory submission outputs, while partnering with Biostatistics, Data Management, and external vendors.

The candidate should have 5+ years of statistical programming experience in biotech/pharma (oncology preferred), with strong ADaM/TLFs, CDISC, define.xml, and Pinnacle 21 expertise.