Principal Clinical Data Standards - R Programmer

Principal Clinical Data Standards Consultant _ Remote

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Principal Data Standards Consultant - R Programmer

The Global Data Standards team is seeking an experienced and innovative Principal Clinical Data Standards Consultant to help drive the evolution of clinical data standards, standards-enabled technologies, and R-based solutions across the organization.

This role offers the opportunity to influence enterprise-wide standards strategy, shape the future of R adoption, and lead the development of scalable solutions that improve efficiency, quality, and regulatory compliance across clinical development programs.

Job Summary

• 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

• 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.

• If you are ready to make a substantial impact in the field of SDTM standards and contribute to cutting-edge projects at ICON, apply now to join our dynamic team!
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include

• 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

• Benefits may vary depending on role and location.
• Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

• ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
• If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
• Are you a current ICON Employee? Please click here to apply