Overview
In this role you will support pharmacometrics by creating and QC’ing NONMEM PK/PD datasets, enabling robust modelling across a global clinical portfolio. You will work with Data Management, Statistical Programming, and Bioanalytical teams to ensure timely, high-quality data that meet regulatory standards. The position emphasizes data standardisation, automation, and contributing to submission-ready datasets within a collaborative, cross-functional environment. You will help advance standardisation initiatives and maintain inspection readiness, shaping pharmacometrics workflows at ICON.
Leistungen / Benefits
- Competitive base salary
- Performance-related incentives
- Health and wellbeing programmes (medical, dental, vision)
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
Verantwortungsbereiche
- Develop and quality control NONMEM PK/PD datasets using SDTM and ADaM data sources
- Deliver accurate, submission-ready datasets to support pharmacometric modelling
- Perform QC of internally and externally produced NONMEM datasets
- Collaborate with Data Management, Statistical Programming, Statistics, Clinical Pharmacology, and Bioanalytical teams to resolve data issues and meet timelines
- Assist in preparation of regulatory submission projects per internal pharmacometrics guidelines
- Quality check customised R packages used to standardise pharmacometric workflows
- Develop and maintain testing frameworks and validation processes for departmental R tools
- Identify data discrepancies and opportunities for automation and efficiency
- Contribute to new pharmacometric standardisation initiatives and ensure SOP/ICH-GCP compliance
Zentrale Anforderungen
- Bachelor's degree in Life Science, Health Science, Statistics, Computer Science, IT, or related discipline
- Minimum 6 years' experience in pharmaceutical, biotechnology, or CRO industry
- Strong programming expertise in R
- Experience developing and quality controlling NONMEM PK/PD datasets
- Working knowledge of PK/PD principles and pharmacometric workflows
- Strong understanding of SDTM, ADaM, and CDISC standards (including controlled terminology)
- Experience supporting NONMEM file creation, QC, submissions, and standardisation activities
- Strong attention to detail and commitment to data quality
- Excellent written and verbal English communication
- Attention to detail
- Cross-functional collaboration
- Problem solving
- R programming
- NONMEM PK/PD data handling
- SDTM/ADaM/CDISC standards
Pharmacometrics Support Programmer Arbeitgeber: Icon Clinical PLC
ICON ist ein hervorragender Arbeitgeber, der Ihnen die Möglichkeit bietet, in einem globalen Team von Fachleuten zu arbeiten, das sich leidenschaftlich für die Entwicklung neuer Medikamente einsetzt. Mit einem starken Fokus auf Zusammenarbeit, Innovation und kontinuierliche Weiterbildung fördert ICON eine inklusive Arbeitskultur, in der Ihre Fähigkeiten geschätzt werden und Sie aktiv zur Verbesserung der Arzneimittelentwicklung beitragen können. Darüber hinaus profitieren Sie von einem wettbewerbsfähigen Vergütungspaket und umfassenden Gesundheits- und Wellnessprogrammen, die auf Ihre berufliche und persönliche Entwicklung ausgerichtet sind.
