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