Senior Pharmacometric Programmer — PK/PD & NONMEM

ICON Strategic Solutions; Reading; On-site; GBP 65,000 - 85,000; Full time

Job summary

ICON Strategic Solutions seeks an experienced Pharmacometrics Support Programmer to join a global FSP team in Reading, UK. The role focuses on creating, quality controlling, and standardising NONMEM PK/PD datasets to support pharmacometric modelling.

You will collaborate with Data Management, Statistical Programming, Statistics, and Bioanalytical teams to ensure high-quality data and timely delivery in line with regulatory standards.

Qualifications

• Strong programming expertise in R.
• Experience developing and quality controlling NONMEM PK/PD datasets.
• Working knowledge of SDTM, ADaM, and CDISC standards.
• Experience supporting NONMEM file creation, quality control, submissions, and standardisation activities.
• Excellent written and verbal communication skills in English.

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.

Skills

R programming

NONMEM PK/PD datasets

SDTM/ADaM standards

PK/PD knowledge

Data quality control

English communication

Education

Bachelor's degree in Life Science/Health Science/Statistics/CS/IT or related

Job description

ICON Strategic Solutions seeks an experienced Pharmacometrics Support Programmer to join a global FSP team in Reading, UK. The role focuses on creating, quality controlling, and standardising NONMEM PK/PD datasets to support pharmacometric modelling.

You will collaborate with Data Management, Statistical Programming, Statistics, and Bioanalytical teams to ensure high-quality data and timely delivery in line with regulatory standards.