Statistical Programmer II; PK

Pharmacometrics Support (base)

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

We are seeking an experienced Pharmacometrics Support Programmer to join a global FSP team. This is an opportunity for a highly analytical programmer with strong R programming expertise and experience in PK/PD data preparation to contribute to critical drug development programmes.

In this role, you will be responsible for the creation, quality control, and standardisation of NONMEM PK/PD datasets, supporting pharmacometric modelling activities across a diverse clinical portfolio. Working closely with Data Management, Statistical Programming, Statistics, Bioanalytical teams, and external partners, you will play a key role in ensuring high-quality pharmacometric data is delivered on time and to the highest regulatory standards.

• 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 ensure project timelines are met.
• Contribute to the preparation of 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.
• Actively contribute to the development and implementation of new pharmacometric standardisation initiatives.
• Ensure all deliverables comply with applicable SOPs, working instructions, regulatory requirements, and ICH-GCP guidelines.
• Maintain inspection readiness through ongoing training and adherence to quality standards.

• 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.

• Opportunity to work within a globally recognised Clinical Pharmacology & Pharmacometrics function.
• Contribute directly to innovative drug development programmes.
• Work in a highly collaborative and scientifically driven environment.
• Be part of ongoing innovation and standardisation initiatives within pharmacometrics and clinical data science.
• Use your expertise to influence best practices and…