Senior Statistical Programmer

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.
Ability to work independently while managing multiple priorities.
Detail‑oriented with a strong commitment to quality and timelines.

Preferred Qualifications
Experience supporting  Translational Medicine or Clinical Pharmacology groups .
Familiarity with internal exploratory analysis and early‑phase decision‑making needs.
Exposure to integrated summaries or pooled PK analyses across studies.