Opportunity Description
Key Responsibilities
Lead the development and validation of CDISC-compliant datasets (SDTM, ADaM) and Tables, Listings, and Figures (TLFs).Design and implement PK, PK/PD, and safety ADaM datasets, ensuring compliance with industry standards and regulatory requirements.Support Population PK (PopPK), PK/PD, and Exposure–Response (ER) analyses by developing and maintaining analysis-ready datasets.Collaborate closely with Clinical Pharmacology, Biostatistics, and Translational Medicine teams to support early-phase decision-making.Provide programming leadership for Phase I / First-in-Human trials, crossover designs, and PK parameter pooling strategies.Contribute to regulatory submissions, ensuring datasets and outputs meet global health authority standards (e.g., FDA, EMA).Develop and maintain standard programming practices, macros, and QC processes to enhance efficiency and quality.Act as a technical lead or SM...
Full time
Mathematical Science Occupations