Principal Statistical Programmer
Job Title: Principal Statistical Programmer
Position Summary
We are seeking a Principal Statistical Programmer to provide full end‑to‑end statistical programming support across clinical development programs. This role requires deep technical expertise, leadership, and hands‑on delivery, covering SDTM, ADaM, TLF development, and regulatory submission support. The Principal Statistical Programmer will serve as a subject matter expert, ensure high‑quality deliverables, and contribute to programming standards and best practices.
Key Responsibilities
- Provide end‑to‑end statistical programming support for clinical studies from study setup through submission
- Lead and perform development and validation of:
- SDTM datasets
- ADaM datasets
- Tables, Listings, and Figures (TLFs)
- Ensure all deliverables are compliant with CDISC standards and regulatory requirements
- Support regulatory submissions (e.g., FDA, EMA), including define.xml, submission‑ready datasets, and reviewer’s guides
- Serve as a Principal‑level programmer, providing technical leadership and guidance to other programmers as needed
- ...
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