About the Role

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.

Key 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 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.

What We're Looking For

• 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.

Desired Skills

• 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.

Why Join Us?

• 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 improve the efficiency and quality of pharmacometric deliverables.

If you are passionate about leveraging R programming, pharmacometrics, and data quality excellence to support drug development, we'd love to hear from you.

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