Principal Clinical Data Standards Consultant – R Programmer

Warman O'Brien; Polska; Remote; PLN 430,000 - 665,000; Full time

Job summary

Warman O'Brien is seeking a Principal Clinical Data Standards Consultant – R Programmer to lead development and governance of SDTM/ADaM standards, build scalable R-based solutions, and design R Shiny dashboards for enterprise-wide programming capabilities.

Ideally, you will mentor statisticians and programmers, influence cross-functional stakeholders, and drive regulatory submissions and data standards at scale.

Qualifications

• 8+ years of experience in clinical trials programming, clinical data standards, or a related discipline.
• Advanced expertise in CDISC SDTM and strong knowledge of ADaM.
• Advanced R programming skills with practical applications.
• Experience with R Shiny and data-driven applications.
• Experience leading technical initiatives and influencing cross-functional stakeholders.
• Strong communication, consulting, mentoring, and problem-solving skills.
• Experience with clinical development, regulatory submissions, and programming standards.

Responsibilities

• Lead the development, implementation, and governance of CDISC SDTM and ADaM standards.
• Develop scalable R programming frameworks, packages, utilities, and automation solutions.
• Design and develop R Shiny applications for dashboards, monitoring, and data-driven solutions.
• Collaborate with cross-functional teams to drive innovation, quality, efficiency, and compliance.

Skills

CDISC SDTM

ADaM

R programming

R Shiny

Cross-functional leadership

Regulatory submissions

Mentoring

Communication

Job description

Principal Clinical Data Standards Consultant – R Programmer

Location: Remote in Bulgaria, Poland or South Africa

We are seeking an experienced Principal Clinical Data Standards Consultant – R Programmer to lead the development and evolution of clinical data standards, R-based solutions, and scalable programming capabilities across clinical development.

Key Responsibilities

• Lead the development, implementation, and governance of CDISC SDTM and ADaM standards.
• Provide expert guidance on SDTM compliance, standards implementation, and regulatory submission requirements.
• Develop scalable R programming frameworks, packages, utilities, and automation solutions.
• Design and develop R Shiny applications for dashboards, monitoring, and data-driven solutions.
• Establish programming best practices through code reviews, standards, and governance.
• Contribute to R adoption strategy, technology roadmaps, and enterprise-wide programming capabilities.
• Develop training and provide mentoring to programmers and statisticians transitioning to R.
• Collaborate with cross-functional teams to drive innovation, quality, efficiency, and compliance.

Requirements

• 8+ years' experience in clinical trials programming, clinical data standards, or a related discipline.
• Advanced expertise in CDISC SDTM and strong knowledge of ADaM.
• Advanced R programming skills.
• Experience with R Shiny and data-driven applications.
• Experience leading technical initiatives and influencing cross-functional stakeholders.
• Strong communication, consulting, mentoring, and problem-solving skills.
• Experience with clinical development, regulatory submissions, and programming standards.

A great opportunity for a senior clinical data standards and R professional to shape technology, standards, and programming capabilities at an enterprise level.