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Pharmacometrics Support Programmer

icon · Reading

New
Senior 🇬🇧 English
NONMEM SDTM ADaM CDISC

Job description

About the role

ICON is looking for an experienced Pharmacometrics Support Programmer to join a global FSP team in Reading. The role suits a highly analytical programmer with strong R programming expertise and PK/PD data preparation experience, who will create, quality control and standardise NONMEM PK/PD datasets for drug development programmes. You will work closely with Data Management, Statistical Programming, Statistics, Bioanalytical teams and external partners.

Key responsibilities

  • Develop and quality control NONMEM PK/PD datasets using SDTM and ADaM data sources.
  • Support pharmacometric modelling by delivering accurate, complete, 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 meet project timelines.
  • Contribute to regulatory submission projects in line with internal pharmacometrics guidelines.
  • Run quality control testing of customised R packages and maintain testing frameworks and validation processes for departmental R tools.
  • Identify data discrepancies, process improvements and automation opportunities, and help build new pharmacometric standardisation initiatives.
  • Ensure deliverables comply with SOPs, working instructions, regulatory requirements and ICH-GCP guidelines, and maintain inspection readiness.

Required profile

  • Bachelor's degree in a Life Science, Health Science, Statistics, Computer Science, IT or related discipline.
  • At least 6 years of experience in the pharmaceutical, biotechnology or CRO industry.
  • Working knowledge of PK/PD principles and pharmacometric workflows.
  • Strong attention to detail, excellent written and verbal English, and ability to work across global, cross-functional teams.

Required skills

  • Strong R programming expertise.
  • Experience developing and quality controlling NONMEM PK/PD datasets.
  • Understanding of SDTM, ADaM and CDISC standards, including controlled terminology.
  • Experience with NONMEM file creation, quality control, submissions and standardisation.
  • Desired: reviewing outsourced programming deliverables, validating customised R packages, and driving standardisation initiatives.

What we offer

  • 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 learning and development opportunities.

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Published 6 hours ago

Expires 1 month from now

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