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PK/PD Statistical Programmer (Home-Based)

iqvia · Reading

New
Senior 🇬🇧 English
NONMEM SDTM ADaM Pharmacometrics

Job description

About the role

IQVIA is seeking an experienced PK/PD Statistical Programmer to work from home, supporting its Pharmacometrics team. The role produces high-quality, compliant datasets for modeling and analysis, ensuring accuracy from early (unclean) through post-lock clinical data. It suits someone with strong R programming skills, hands-on NONMEM dataset creation 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.
  • Create high-quality PK/PD datasets for pre-lock and post-lock clinical data.
  • Execute medium to high complexity programming tasks accurately and on time.
  • Review data, spot inconsistencies or gaps and propose solutions to improve quality and efficiency.
  • Perform QC of NONMEM datasets, including those produced by external partners.
  • Support preparation of deliverables for regulatory submissions following internal Pharmacometrics guidelines.
  • QC customized R packages used in pharmacometrics workflows and build or enhance automated test suites.
  • Liaise with Data Management, Biostatistics, Statistical Programming and Bioanalytical teams to resolve data issues.
  • Follow SOPs and regulatory standards and contribute to new PM standardization initiatives.

Required profile

  • Bachelor's or Master's degree in health, science, IT, mathematics or a related field.
  • At least 6 years of industry experience in clinical data analysis, statistical programming or pharmacometrics support.
  • Expert-level R for data processing, dataset creation and QC automation.
  • Hands-on experience creating NONMEM datasets, including complex structures for PK/PD analyses.
  • Strong understanding of SDTM, ADaM and controlled terminology, plus applied PK/PD and clinical trial knowledge.
  • Attention to detail, strong analytical, documentation and communication skills, and ability to work independently and across global teams.

Preferred skills

  • Building standardized workflows for NONMEM dataset creation, submission packages and QC.
  • R package testing, validation frameworks or reproducible programming practices.
  • Familiarity with pharmacometrics workflows in clinical or real-world settings.

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Source : ats:workday

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Published 4 hours ago

Expires 1 month from now

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