Principal Clinical Data Standards, R Programmer

ICON plc

. Develop, implement, and maintain ICON SDTM and ADaM standards libraries from data collection through analysis and submission .

Posted 9/21/2026full-timeRemote • South Africa, Poland, BulgariaLeadWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in CDISC SDTM and ADaM standards, with a strong focus on R programming and R Shiny application development for clinical data management. Proven ability to lead technical initiatives, mentor teams, and ensure compliance with regulatory standards.

Highest-signal resume keywords

CDISC SDTM Standards ImplementationAdvanced R ProgrammingR Shiny DevelopmentClinical Trials ProgrammingData Standards Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CDISC SDTM StandardsADaM StandardsR ProgrammingR Shiny ApplicationsClinical Data StandardsProgramming FrameworksReusable R PackagesData AnalysisCode ReviewsAutomation Tools

Soft Skills

Excellent CommunicationConsulting SkillsMentoringProblem-SolvingInfluencing Stakeholders

Industry Keywords

Clinical TrialsData Standards GovernanceRegulatory SubmissionStandards ComplianceData Monitoring Committee

About the role

Key responsibilities & impact

Develop, implement, and maintain ICON SDTM and ADaM standards libraries from data collection through analysis and submission
Support sponsors in the development, implementation, maintenance, and governance of clinical data standards content
Provide internal and external consulting on SDTM compliance, standards implementation, and industry best practices
Participate in standards governance team meetings and provide standards input as assigned
Support the development and maintenance of technologies used to implement and manage clinical data standards
Design and implement standardized programming frameworks for clinical reporting, analysis, and submission deliverables
Develop and deliver training on CDISC standards-related topics for internal teams and external sponsors
Provide expert guidance and hands-on support for study-specific R programming activities
Develop and maintain reusable R packages, functions, utilities, and automation tools, with a specific focus on SDTM processes and deliverables
Design and develop R Shiny applications to support dashboards and a Data Monitoring Committee initiative
Perform code reviews and establish best practices to ensure quality, consistency, scalability, and compliance
Partner with the R Business Solutions Organization to advise on R adoption strategy and roadmap
Drive the development of scalable templates, workflows, and governance models that support enterprise-wide R adoption
Contribute to departmental technology strategy and help shape future programming capabilities
Mentor and coach programmers and statisticians transitioning to R
Support onboarding and enablement activities for new R users

Requirements

What you’ll need

Minimum of 8 years of experience in clinical trials programming, data standards management, or a related clinical data science discipline
Advanced expertise in CDISC SDTM standards, including implementation, governance, compliance, and regulatory submission requirements
Working knowledge of ADaM standards and standards development across the clinical data lifecycle a plus
Advanced proficiency in R programming
Hands-on R Shiny development experience, particularly for dashboards or data-driven applications a plus
Demonstrated ability to lead technical initiatives and influence cross-functional stakeholders
Excellent communication, consulting, mentoring, and problem-solving skills
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