Job Description

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