# Principal Clinical Data Standards Consultant

**Company**: ICON
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Data Science
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/South-Africa-Johannesburg/Principal-Clinical-Data-Standards---R-Programmer_JR155667?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_16e7308b-b9f

## 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

## Skills

### Required
- R programming
- CDISC SDTM standards
- ADaM standards
- clinical data standards
- R Shiny development

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Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/South-Africa-Johannesburg/Principal-Clinical-Data-Standards---R-Programmer_JR155667?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)