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 m...