Clinical Development
PK/PD Statistical Programmer (m/w/d) - homebased
Resumé
The role develops, validates, and quality-checks PK/PD datasets and R-based workflows for pharmacometrics and regulatory submissions. It collaborates with cross-functional teams to resolve data issues and improve standards.
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Kort om jobbet
Employment type: Full time; Home-based. Requisition: R1573232. We are seeking an experienced PK/PD Statistical Programmer with strong experience in R programming, PK/PD datasets, and NONMEM dataset creation. This role supports Pharmacometrics by producing high‑quality, compliant datasets for modeling and analysis, ensuring accuracy from early (unclean) through post‑lock clinical data.
The ideal candidate brings deep technical expertise, strong problem‑solving skills, and a solid understanding of PK/PD principles. Key Responsibilities Program, validate, and deliver NONMEM‑ready PK/PD datasets based on SDTM/ADaM standards using advanced R programming skills. Create high‑quality PK/PD datasets for both pre‑lock and post‑lock clinical data.
Independently execute programming tasks of medium to high complexity with excellent accuracy and timeliness. Critically review data, identify inconsistencies or gaps, and propose solutions to improve dataset quality and programming efficiency. Perform quality control (QC) of NONMEM datasets, including those produced by external partners.
Support preparation of deliverables for regulatory submissions following internal Pharmacometrics guidelines. Conduct QC of customized R packages used for pharmacometrics workflows; enhance or build automated test suites where needed1 …
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