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

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 t...