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‑HumanCrossover studiesExposure–response analysisPK parameter poolingExperience
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.
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