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ICON plc

Statistical Programmer II

ICON plc

. Develop and quality control NONMEM PK/PD datasets using SDTM and ADaM data sources .

Posted 10/9/2026full-timeRemote • United Kingdom, France, Germany, Poland, Ireland, South AfricaMid-LevelSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates strong programming expertise in R and extensive experience in developing and quality controlling NONMEM PK/PD datasets, ensuring compliance with regulatory requirements and internal guidelines. Proven ability to collaborate effectively across cross-functional teams and drive standardisation initiatives within the pharmaceutical industry.

Highest-signal resume keywords
R Programming ExpertiseNONMEM PK/PD Dataset DevelopmentSDTM and ADaM Standards KnowledgeQuality Control and Validation of R PackagesCross-Functional Team Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
R ProgrammingNONMEM Dataset DevelopmentQuality ControlPharmacometric WorkflowsSDTM StandardsADaM StandardsCDISC StandardsData Discrepancy IdentificationProcess ImprovementAutomation Opportunities
Soft Skills
Attention to DetailExcellent Communication Skills
Tools & Technologies
NONMEMR PackagesTesting Frameworks
Industry Keywords
Pharmaceutical IndustryBiotechnologyCRORegulatory SubmissionICH-GCP Guidelines

About the role

Key responsibilities & impact
  • 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 meet project timelines
  • Contribute to 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 automation and efficiency
  • Contribute to new pharmacometric standardisation initiatives
  • Ensure deliverables comply with SOPs, working instructions, regulatory requirements, and ICH-GCP guidelines
  • Maintain inspection readiness through ongoing training and adherence to quality standards

Requirements

What you’ll need
  • 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
  • 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
  • Legal right to work in the country where the role is based

Benefits

Comp & perks
  • 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
  • Collaborative environment
  • Stability and career development
  • Opportunity to work within a globally recognised Clinical Pharmacology & Pharmacometrics function
  • Contribution to innovative drug development programmes
  • Ongoing innovation and standardisation initiatives within pharmacometrics and clinical data science