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 Translation...