[Hiring] Statistical Programmer II @ICON plc

Role Description

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

Qualifications

• 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.

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.
• Benefits may vary depending on role and location.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request.