Senior Statistical Programmer

Role: Senior statistical programmer supporting global early development studies and PK/PD modeling across various therapeutic areas, focusing on high-quality data analysis and regulatory submission deliverables. Responsibilities: develop, validate, and maintain complex datasets, tables, listings, and figures; provide analytical support to statisticians and pharmacokinetic modelers; prepare programming for regulatory documents; ensure data traceability; contribute to programming standards. Requirements: BA/BS with 5-9 years or MS with 3-7 years SAS/R experience in clinical trials; strong knowledge of CDISC SDTM and ADaM standards; expertise in data manipulation, analysis, and reporting; ability to develop complex algorithms and interpret analysis plans; experience with non-standard data formats in pharmaceutical research. Preferred: pharmacokinetic data programming, clinical pharmacology concepts, additional software proficiency (e.g., Python, NONMEM), and experience managing large databases; familiarity with SDLC and SOPs. HighValue: clinical trial environment, early development stage, regulatory submission support, cross-functional collaboration with statisticians and PK modelers, hybrid work setup, 10% travel.