Principal Clinical Data Standards, R Programmer

This is a fully remote position, open to applicants in South Africa, +2 more countries.

📋 Description

• Develop, implement, and sustain ICON SDTM and ADaM standards libraries from data acquisition through analysis and submission.

• Assist sponsors in the creation, execution, upkeep, and governance of clinical data standards content.

• Offer internal and external consultation on SDTM compliance, standards execution, and best practices within the industry.

• Engage in standards governance team meetings and provide input on standards as assigned.

• Aid in the development and maintenance of technologies utilized to implement and manage clinical data standards.

• Design and create standardized programming frameworks for clinical reporting, analysis, and submission deliverables.

• Create and present training sessions on CDISC standards-related topics for internal teams and external sponsors.

• Provide expert advice and hands-on support for study-specific R programming tasks.

• Develop and maintain reusable R packages, functions, utilities, and automation tools, particularly focusing on SDTM processes and deliverables.

• Design and develop R Shiny applications to support dashboards and a Data Monitoring Committee initiative.

• Conduct code reviews and establish best practices to ensure quality, consistency, scalability, and compliance.

• Collaborate with the R Business Solutions Organization to provide guidance on R adoption strategy and roadmap.

• Lead the development of scalable templates, workflows, and governance models that facilitate enterprise-wide R adoption.

• Contribute to the departmental technology strategy and assist in shaping future programming capabilities.

• Mentor and coach programmers and statisticians transitioning to R.

• Support onboarding and enablement efforts for new R users.

⛳️ Requirements

• A minimum of 8 years of experience in clinical trials programming, data standards management, or a related clinical data science field.

• Advanced knowledge of CDISC SDTM standards, including implementation, governance, compliance, and regulatory submission requirements.

• Familiarity with ADaM standards and standards development throughout the clinical data lifecycle is a plus.

• Advanced proficiency in R programming.

• Experience in R Shiny development, especially for dashboards or data-driven applications, is advantageous.

• Proven ability to lead technical initiatives and influence cross-functional stakeholders.

• Excellent communication, consulting, mentoring, and problem-solving abilities.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Learning and development opportunities through structured training and career pathways.