**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 **regulatory submissions** is required.

**Soft Skills**

+ Strong communication and stakeholder management skills.
+ Abi...