Pharmacometrics Support Programmer
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Job Description
Pharmacometrics programmer developing and validating NONMEM PK/PD datasets for ICON, a global healthcare intelligence and clinical research organisation. Supporting R-based standardisation and regulatory drug development programmes.
Responsibilities:
- Develop and quality control NONMEM PK/PD datasets using SDTM and ADaM data sources
- Support pharmacometric modelling activities by delivering accurate, complete, and submission-ready datasets
- Perform quality review 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 project timelines
- Contribute to regulatory submission projects in accordance with internal pharmacometrics guidelines
- Conduct quality control testing of customised R packages used to standardise pharmacometric workflows
- Develop and maintain testing frameworks and validation processes for departmental R tools and packages
- Identify data discrepancies, process improvements, and opportunities for greater automation and efficiency
- Contribute to new pharmacometric standardisation initiatives
- Ensure deliverables comply with SOPs, working instructions, regulatory requirements, and ICH-GCP guidelines
- Maintain inspection readiness through ongoing training and adherence to quality standards
Requirements:
- Bachelor's degree in a Life Science, Health Science, Statistics, Computer Science, IT, or related discipline
- Minimum of 6 years' experience within the 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, quality control, submissions, and standardisation activities
- Strong attention to detail and commitment to data quality
- Excellent written and verbal communication skills in English
- Experience reviewing and managing outsourced programming deliverables
- Experience validating or quality controlling customised R packages
- Demonstrated ability to identify process improvements and drive standardisation initiatives
- Ability to work effectively across global, cross-functional teams
- Legal right to work in the country where the role is based
Benefits:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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