Description
We are 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.
Responsibilities:
- 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.
Rewards & Benefits
- 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