Principal Statistical Programmer (PK/PD) (m/w/d)

Job 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 SME, mentoring junior programmers and guiding project delivery. - Ensure adherence to timelines, quality standards, and documentation requirements. - Support integrated analyses and pooled PK datasets across studies where required. Required Skills & Experien...