Description
We are seeking an experienced Pharmacometrics Support Programmer to join a global FSP team. As a Pharmacometrics Support Programmer, 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.
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.
Rewards & 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