Senior Statistical Programmer

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

Principal / Senior Statistical Programmer

Growing biotech/pharma company seeking a Senior Statistical Programmer to support Phase I-III clinical development programs. This individual will play a key role in the development of analysis datasets, statistical outputs, and regulatory submission deliverables while partnering closely with Biostatistics, Data Management, and external vendors.

Responsibilities:

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

Key Requirements:

• BS/MS in Statistics, Biostatistics, Computer Science, Mathematics, or related field
• 5+ years of statistical programming experience within biotech/pharma; oncology experience 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 preferred
• Demonstrated interest in automation and AI-enabled programming solutions