PK/PD Statistical Programmer – homebased

Job not on LinkedIn

🕒 May 20

🌐 Germany, France, +2 more countries – Remote

🇩🇪 Germany – Remote 🇫🇷 France – Remote 🇪🇸 Spain – Remote 🇭🇺 Hungary – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🖥 Software Engineer

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IQVIA

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

🏭 Manufacturing

📣 Marketing

💰 $1G Post-IPO Debt on 2023-05

Consulting • Manufacturing • Marketing

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

📋 Description

• Program, validate, and deliver NONMEM-ready PK/PD datasets based on SDTM/ADaM standards using advanced R programming skills • Create PK/PD datasets for pre-lock and post-lock clinical data • Execute medium- to high-complexity programming tasks accurately and on time • Review data, identify inconsistencies or gaps, and propose solutions to improve dataset quality and programming efficiency • Perform quality control of NONMEM datasets, including datasets produced by external partners • Support preparation of regulatory submission deliverables according to internal Pharmacometrics guidelines • Conduct QC of 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 and ensure alignment • Follow SOPs, work instructions, and regulatory standards while maintaining inspection readiness • Contribute as a technical driver to new PM standardization initiatives for dataset creation and QC

🎯 Requirements

• 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 • 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 • 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