Clinical R programmer Consultant

This position is based in the United States and supports innovative clinical development programs by delivering high-quality programming solutions for clinical trial data and regulatory submissions.

About the Role

The Clinical R Programmer Consultant will focus on developing and validating clinical datasets using R while ensuring compliance with industry standards. The consultant will collaborate closely with biostatistics, data management, and clinical teams to support critical trial deliverables, contribute to modern clinical programming workflows, automation initiatives, and reproducible reporting practices. This role combines technical expertise in R with strong knowledge of clinical data standards and regulatory expectations.

Responsibilities

• Develop, validate, and maintain SDTM and ADaM datasets using R while following CDISC standards and clinical programming best practices.
• Create and maintain efficient, reproducible R scripts for clinical data analysis, reporting, and automation workflows.
• Support the generation of tables, listings, and figures (TLFs) using R and SAS when required.
• Collaborate with statisticians, clinical data managers, and cross-functional teams to understand programming requirements and deliver high-quality outputs.
• Perform quality control checks, investigate data discrepancies, and ensure programming deliverables meet regulatory expectations.
• Support clinical trial programming activities, documentation, and version control processes.
• Contribute to the development and improvement of R-based programming pipelines and automation solutions.
• Apply knowledge of regulatory standards, including FDA and EMA expectations, to ensure compliant clinical data outputs.
• Utilize SAS programming capabilities to support legacy studies and additional programming needs.
• Promote reproducible programming practices through structured workflows, documentation, and efficient code development.

Requirements

• Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related technical field.
• 2+ years of experience in clinical programming, with a strong focus on R-based development.
• Demonstrated experience creating SDTM and ADaM datasets using R.
• Working knowledge of SAS programming in a clinical research environment.
• Strong understanding of CDISC standards, including SDTM and ADaM.
• Experience supporting clinical trial data, regulatory submissions, and quality control processes.
• Strong analytical, problem-solving, and documentation skills.
• Ability to write clear, maintainable, and reproducible programming code.
• Experience with R packages such as tidyverse, haven, pharmaverse tools (including admiral or tidyCDISC), or similar clinical programming frameworks preferred.
• Knowledge of R Markdown, Shiny applications, or reproducible reporting solutions preferred.
• Exposure to GxP validation practices, Git/version control, and automated workflows preferred.
• Previous experience within a CRO, pharmaceutical, biotechnology, or healthcare environment is a plus.

Benefits

• Opportunity to work directly with a dedicated client while benefiting from the resources and career opportunities of a global organization.
• Remote work flexibility.
• Exposure to innovative clinical programming practices and modern R-based technologies.
• Opportunity to contribute to impactful clinical development programs.
• Collaborative environment with experienced professionals across clinical, statistical, and data teams.
• Professional development and continuous learning opportunities.
• Access to diverse career opportunities within the life sciences and clinical research industry.