Principal Clinical Data Standards, R Programmer

🔥 2 hours ago

🌐 South Africa, Poland, +1 more countries – Remote

🇿🇦 South Africa – Remote 🇵🇱 Poland – Remote 🇧🇬 Bulgaria – Remote

⏰ Full Time

🔴 Lead

🖥 Software Engineer

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• 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 • Legal right to work in the country where the role is based

🏖️ 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