Full time

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

Posted by IQVIA • Copenhagen, Capital Region of Denmark, Denmark

📍 Copenhagen, Capital Region of Denmark 🕒 June 08, 2026

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About the Role

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...
                

Job Details

Location Copenhagen, Capital Region of Denmark
Job Type Full time
Category Mathematical Science Occupations
Posted June 08, 2026
Deadline July 18, 2026

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