Principal Clinical Data Standards Consultant - Remote

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!

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.

Our benefits examples include:

• 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.

• Visit our careers site to read more about the benefits ICON offers.

• 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 discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

• If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.