**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 SME, mentoring junior pro...