Pharmacometrics Support Programmer

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Create and ensure quality control of NONMEM PK/PD datasets utilizing SDTM and ADaM data sources.

• Aid pharmacometric modeling efforts by providing datasets that are accurate, comprehensive, and ready for submission.

• Conduct quality assessments of NONMEM datasets produced both internally and externally.

• Work in partnership with Data Management, Statistical Programming, Statistics, Clinical Pharmacology, and Bioanalytical teams to address data challenges and adhere to project deadlines.

• Play a role in regulatory submission projects according to internal pharmacometrics guidelines.

• Execute quality control testing on customized R packages designed to streamline pharmacometric workflows.

• Design and uphold testing frameworks and validation processes for departmental R tools and packages.

• Detect data inconsistencies, suggest process enhancements, and explore opportunities for increased automation and efficiency.

• Contribute to initiatives aimed at standardizing pharmacometrics.

• Ensure that deliverables align with SOPs, working instructions, regulatory standards, and ICH-GCP guidelines.

• Maintain readiness for inspections through continuous training and compliance with quality standards.

⛳️ Requirements

• A Bachelor’s degree in Life Science, Health Science, Statistics, Computer Science, IT, or a related field.

• At least 6 years of experience in the pharmaceutical, biotechnology, or CRO industry.

• Proficiency in programming with R.

• Experience in developing and maintaining quality control for NONMEM PK/PD datasets.

• Familiarity with PK/PD principles and pharmacometric workflows.

• Strong knowledge of SDTM, ADaM, and CDISC standards, including controlled terminology.

• Experience in supporting the creation, quality control, submission, and standardization of NONMEM files.

• Meticulous attention to detail and a commitment to data integrity.

• Exceptional written and verbal communication skills in English.

• Experience in reviewing and managing programming deliverables from external sources.

• Experience in validating or conducting quality control on customized R packages.

• Proven ability to recognize opportunities for process improvements and to lead standardization initiatives.

• Capability to work effectively across global, cross-functional teams.

• Legal eligibility to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.