remote
Senior Principal Statistical Programmer - Novartis
Software Engineer
Senior Principal Statistical Programmer leading complex clinical development programming, driving modern practices and regulatory‑ready outputs using SAS, R, Python and SQL across high‑impact studies.
About the role
Key Responsibilities
- Lead end‑to‑end statistical programming for large, multi‑arm clinical trials, ensuring accuracy and regulatory compliance.
- Design and implement efficient, reusable code frameworks in SAS, R, and Python to support data analysis and reporting.
- Collaborate with biostatisticians, data managers, and clinical teams to translate study protocols into robust programming plans.
- Mentor and coach junior programmers, fostering best practices and continuous improvement.
- Oversee the creation of high‑quality, regulatory‑ready outputs, including tables, listings, and figures (TLFs) for INDs, NDAs, and BLA submissions.
Requirements
- 10+ years of experience in statistical programming within the pharmaceutical or biotech industry.
- Expertise in SAS (Base, Macro, PROC), R, Python, and SQL for data manipulation and analysis.
- Strong understanding of regulatory guidelines (FDA, EMA) and submission processes.
- Proven ability to lead cross‑functional teams and deliver complex programming solutions on schedule.
- Excellent communication skills and a collaborative mindset.