Job Description
Required Skills & Experience
Technical Skills
- Expert‑level SAS programming skills.
- Strong, hands‑on experience with CDISC SDTM, ADaM and TLFs.
- Proven experience developing safety, PK, and PK/PD ADaM datasets.
- Experience supporting POPPK/popPD/Exposure Response(ER) dataset creation workflows.
- Solid understanding of early‑phase clinical trial designs, including:
- Phase I / First‑in‑Human
- Crossover studies
- Exposure–response analysis
- PK parameter pooling
Experience
- 8+ years of statistical programming experience in the pharmaceutical or CRO environment.
- Demonstrated experience as a Lead Programmer or technical lead.
- Prior experience working in an FSP engagement model preferred.
- Experience supporting regul...