PK/PD Statistical Programmer – homebased

🔥 12 hours ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🖥 Software Engineer

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

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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 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 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 and enhance or build automated test suites where needed • Liaise with 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 to new PM standardization initiatives related to 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