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

IQVIA

Dublin

On-site

EUR 90,000 - 120,000

Full time

3 days ago
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Job summary

IQVIA is seeking an experienced PK/PD Statistical Programmer in Ireland to join our global Pharmacometrics team. You will create NONMEM-ready PK/PD datasets, validate data against SDTM/ADaM standards, and deliver high-quality datasets for modeling and regulatory submissions.

The role requires expert R programming, strong problem-solving skills, and the ability to work across cross-functional teams to ensure data integrity from early unclean data through post-lock analysis.

Qualifications

  • Bachelor’s or Master’s degree in a health, science, IT, mathematics, or related field.
  • Minimum 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.

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

Education

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

Tools

R package testing
Reproducible programming practices

Job description

IQVIA is seeking an experienced PK/PD Statistical Programmer in Ireland to join our global Pharmacometrics team. You will create NONMEM-ready PK/PD datasets, validate data against SDTM/ADaM standards, and deliver high-quality datasets for modeling and regulatory submissions.

The role requires expert R programming, strong problem-solving skills, and the ability to work across cross-functional teams to ensure data integrity from early unclean data through post-lock analysis.

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