Principal Clinical Data Standards Consultant - R Programmer

About the role

ICON, a global healthcare intelligence and clinical research organisation, is looking for an experienced Principal Clinical Data Standards Consultant (R Programmer) to help drive the evolution of clinical data standards, standards-enabled technologies and R-based solutions. The role influences enterprise-wide standards strategy, shapes the future of R adoption and leads scalable solutions that improve efficiency, quality and regulatory compliance across clinical development programs. The position is listed as remote.

Key responsibilities

• Develop, implement and maintain ICON SDTM and ADaM standards libraries from data collection through analysis and submission.
• Support sponsors in developing, implementing, maintaining and governing clinical data standards content.
• Provide internal and external consulting on SDTM compliance, standards implementation and industry best practices.
• Take part in standards governance team meetings and give standards input as assigned.
• Support technologies used to implement and manage clinical data standards, and design programming frameworks for clinical reporting, analysis and submission.
• Deliver training on CDISC standards to internal teams and external sponsors, and guide study-specific R programming.
• Build reusable R packages, functions, utilities and automation tools focused on SDTM, and develop R Shiny applications for dashboards and a Data Monitoring Committee initiative.
• Review code, set best practices and partner with the R Business Solutions Organization on R adoption strategy and roadmap.
• Mentor programmers and statisticians moving to R, support onboarding of new R users and contribute to departmental technology strategy.

Required profile

• Minimum of 8 years of experience in clinical trials programming, data standards management or a related clinical data science discipline.
• 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.

Required skills

• Advanced expertise in CDISC SDTM standards, including implementation, governance, compliance and regulatory submission.
• Working knowledge of ADaM standards is a plus.
• Advanced proficiency in R programming.
• Hands-on R Shiny development experience, especially for dashboards, is a plus.

What we offer

• 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 learning and development opportunities.