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

Company

IQVIA

Location

Copenhagen, Capital Region of Denmark

Type

Full time

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...

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