Principal Data Scientist Consultant – R Programmer

This is a fully remote position, open to applicants in United States.

📋 Description

• Design, verify, and sustain SDTM and ADaM datasets in R — utilizing admiral and the comprehensive pharmaverse — in accordance with CDISC standards.

• Create Tables, Listings, and Figures (TLFs) in R or SAS as dictated by study requirements.

• Conduct Pinnacle21 validation, address findings, and enhance specifications to guarantee CDISC compliance and readiness for submission.

• Develop efficient, reproducible, and well-organized R code for clinical data analysis and reporting.

• Contribute to both open-source and internal tools — including R Shiny / teal modules, R packages, SAS macros, and Python utilities — utilized by clinical programming, data management, and biostatistics teams.

• Collaborate with statisticians, data managers, and clinical teams to convert programming requirements into dependable deliverables.

• Execute quality control, resolve data discrepancies, and ensure outputs align with regulatory standards (e.g., FDA, EMA).

• Assist in automation, pipeline development, and version-controlled workflows.

• Employ SAS for legacy studies or in scenarios where SAS support is necessary.

⛳️ Requirements

• Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related discipline.

• Over 5 years of experience in clinical programming, with a significant emphasis on R.

• Demonstrated expertise in generating SDTM and ADaM datasets in R, including practical experience with admiral.

• Familiarity with Pinnacle21 validation and remediation processes.

• Proficient in SAS programming.

• Working knowledge of Python for analytics, scripting, or tool development.

• Strong grasp of CDISC standards (SDTM, ADaM) and metadata-driven programming.

• Experience with clinical trial data, regulatory submissions, and quality control processes.

• Excellent analytical, problem-solving, and documentation capabilities.

🏝️ Benefits

• Opportunities for professional growth and development.

• Options for remote work.