Principal Clinical Data Standards

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.

What ICON can offer you

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discr