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IQVIA

Runs drug trials and sells health data to pharma

PK/PD Statistical Programmer - m/w/d, Homebased

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-timeNo salary listedRemote

About the Job

Requirements

  • Bachelor’s or Master’s degree in a health, science, information technology, 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.
  • 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.

Desired Qualifications

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

About the Company

IQVIA

Runs drug trials and sells health data to pharma

IQVIA runs clinical trials for drug, biotech and medical device companies and sells them the health data, software and analytics they use to develop and market treatments. Its research arm designs studies, recruits trial sites and patients, and manages trials through to regulatory filing. Its commercial arm sells market data, consulting and software that pharma sales and marketing teams use to plan product launches. Clients pay through multi-year service contracts and data and software subscriptions. IQVIA was formed in 2016 when clinical research firm Quintiles merged with health data company IMS Health, and it is based in Durham, North Carolina.

Company size
10,001+
Company stage
IPO
Headquarters
Durham, NC
Founded
1998

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