Senior PK/PD Programmer – R, NONMEM & Data QC

IQVIA

Stockholms kommun

On-site

SEK 900,000 - 1,100,000

Full time

13 days ago

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Job summary

IQVIA seeks an experienced PK/PD Statistical Programmer to deliver NONMEM-ready PK/PD datasets using R, SDTM/ADaM standards, and rigorous QC. The role requires 6+ years in clinical data analysis or pharmacometrics and deep PK/PD knowledge.

You will collaborate with Data Management, Biostatistics, and other teams globally; ensure regulatory-ready data and robust documentation. A Master’s degree or higher is preferred.

Qualifications

  • Bachelor’s or Master’s degree in health, science, IT, mathematics, or related field.
  • 6+ years of industry experience in clinical data analysis, statistical programming, or pharmacometrics support.
  • Expert-level proficiency in R for data processing, dataset creation, and QC automation. Hands-on experience creating NONMEM datasets, including complex data structures for PK/PD analyses.
  • Strong understanding of SDTM, ADaM, and controlled terminology. Applied knowledge of PK/PD principles and clinical trial concepts.
  • High attention to detail with strong analytical, documentation, and communication skills.
  • Ability to work independently and collaboratively across global, cross-functional teams

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 needed.
  • Liaise with cross-functional teams including Data Management, Biostatistics, Statistical Programming, and Bioanalytical groups to resolve data issues and ensure alignment.
  • Adhere to relevant SOPs, working instructions, and regulatory standards; maintain inspection readiness.
  • Contribute as a technical driver in the development and improvement of new PM standardization initiatives related to dataset creation and QC.

Skills

R programming
PK/PD datasets
NONMEM dataset creation
SDTM
ADaM
PK/PD principles
data management
QC automation
regulatory standards
SOPs
cross-functional teamwork

Education

Bachelor’s or Master’s degree in health, science, IT, mathematics, or related field

Tools

R
NONMEM

Job description

IQVIA seeks an experienced PK/PD Statistical Programmer to deliver NONMEM-ready PK/PD datasets using R, SDTM/ADaM standards, and rigorous QC. The role requires 6+ years in clinical data analysis or pharmacometrics and deep PK/PD knowledge.

You will collaborate with Data Management, Biostatistics, and other teams globally; ensure regulatory-ready data and robust documentation. A Master’s degree or higher is preferred.

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