Principal Clinical Data Scientist Consultant
New
C
ClinChoiceClinical Research
Location: United StatesFull-TimePrincipal
Salary not disclosed
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Job Details
- Experience
- 5+ years in clinical programming
- Required Skills
- PythonR
Requirements
- 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.
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 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.
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