PK/PD Statistical Programmer – homebased

🔥 il y a 11 heures

🇬🇧 Royaume-Uni – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🖥 Ingénieur Logiciel

🇬🇧 Parrain de Visa de Travailleur Qualifié UK

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👻 Score fantôme 10%

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🗣️🇺🇸🇬🇧 Anglais requis

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IQVIA

10 000+ employés

💼 Conseil

🏭 Fabrication

📣 Marketing

💰 €1 000 000 000 Post-IPO Debt en 2023-05

Consulting • Manufacturing • Marketing

IQVIA est un leader mondial dans le domaine de l'analyse de données et des solutions technologiques, dédié à l'amélioration des résultats de santé. L'entreprise utilise sa plateforme Connected Intelligence pour exploiter la puissance des analyses de données avancées et de l'intelligence artificielle, favorisant ainsi l'innovation dans le secteur de la santé. IQVIA se concentre sur divers domaines, y compris la recherche clinique, la technologie et les services de conseil, afin de résoudre des défis complexes dans le domaine de la santé et d'accélérer la livraison de nouvelles thérapies aux 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

🎯 Exigences

• 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

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