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Global drug and device development services

Pharmacometrics Support Programmer

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-timeNo salary listed

About the Job

Requirements

  • A bachelor's degree in a Life Science, Health Science, Statistics, Computer Science, IT, or related discipline is required.
  • At least 6 years of experience in the pharmaceutical, biotechnology, or CRO industry is required.
  • Strong programming expertise in R is required.
  • Experience developing and quality controlling NONMEM PK/PD datasets is required.
  • Working knowledge of PK/PD principles and pharmacometric workflows is required.
  • Strong understanding of SDTM, ADaM, and CDISC standards, including controlled terminology, is required.
  • Experience supporting NONMEM file creation, quality control, submissions, and standardisation activities is required.
  • Strong attention to detail and commitment to data quality are required.
  • Excellent written and verbal communication skills in English are required.

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.
  • Contribute to the development and implementation of new pharmacometric standardisation initiatives.
  • Ensure deliverables comply with applicable SOPs, working instructions, regulatory requirements, and ICH-GCP guidelines.
  • Maintain inspection readiness through ongoing training and adherence to quality standards.

Desired Qualifications

  • 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.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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