Principal Data Scientist Consultant

The Principal Clinical Data Scientist Consultant – R Programmer role at ClinChoice involves working directly for a single sponsor while leveraging the security and career opportunities of a global CRO. Reporting to the Director of Statistical Programming, this role combines hands-on clinical deliverables with contributions to open-source and internal tooling.

About the role

This role is open to remote candidates and requires a blend of clinical programming, data management, and biostatistics expertise. The ideal candidate should have strong R skills, extensive clinical programming experience, and a keen interest in modern, reproducible workflows.

Key Responsibilities

• Develop, validate, and maintain SDTM and ADaM datasets in R using admiral and the broader pharmaverse, following CDISC standards.
• Generate Tables, Listings, and Figures (TLFs) in R or SAS as required by study needs.
• Perform Pinnacle21 validation, resolve findings, and refine specifications to ensure CDISC compliance and submission readiness.
• Write efficient, reproducible, well-structured R code for clinical data analysis and reporting.
• Contribute to open-source and internal tooling, including R Shiny / teal modules, R packages, SAS macros, and Python utilities, used by clinical programming, data management, and biostatistics teams.
• Partner with statisticians, data managers, and clinical teams to translate programming requirements into reliable deliverables.
• Perform Quality Control (QC), reconcile data issues, and ensure outputs meet regulatory expectations (e.g., FDA, EMA).
• Support automation, pipeline development, and version-controlled workflows.
• Use SAS for legacy studies or where SAS support is needed.

Required Qualifications

• Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field.
• 5+ years in clinical programming, with a strong focus on R.
• Proven experience producing SDTM and ADaM datasets in R, including hands-on use of admiral.
• Experience with Pinnacle21 validation and remediation.
• Working knowledge of SAS programming.
• Working knowledge of Python for analytics, scripting, or tooling.
• Solid understanding of CDISC standards (SDTM, ADaM) and metadata-driven programming.
• Experience with clinical trial data, regulatory submissions, and QC processes.
• Strong analytical, problem-solving, and documentation skills.

Preferred Qualifications

• Broader pharmaverse experience (e.g., tidyCDISC, rtables) and tidyverse fluency.
• Experience building or contributing to R Shiny apps, teal modules, or R packages used by other teams.
• Exposure to AI/ML tooling in a clinical or programming context.
• RWE experience — e.g., mapping Flatiron or claims/EHR data into CDISC-aligned structures.
• R Markdown, Quarto, or other reproducible reporting workflows.
• GxP validation, Git-based version control, and CI/CD or automated workflows.
• CRO or pharmaceutical industry experience.