Data Scientist - Statistical Programmer (f/m/x)
Core
Statistical Programmer responsible for authoring Statistical Analysis Plans and executing regulatory-grade programming for the validation of Digital Health Technologies.
Role type
Senior Statistical Programmer (Regulatory Validation)
Builds
Regulatory submission packages and validation documentation for Digital Health Technologies
Domain
Digital Health / Clinical Validation / Regulatory Compliance
Deliverable
production ML models | dashboards & analysis
Required skills
Statistical Analysis Plan (SAP) authoring, Python for statistical programming, Bland-Altman analysis, mixed-effects models, CDISC data mapping, FDA/EMA regulatory standards knowledge, software development best practices (Git, unit testing)
Preferred skills
Experience in pharmaceutical, medical device, or CRO sectors
Technologies
Python, R, Git
Responsibilities
Designing Statistical Analysis Plans for Clinical Validation, Selecting and documenting statistical methods to meet FDA/EMA requirements, Writing clean, modular, and well-documented code to generate datasets and outputs, Implementing software development best practices including version control and automated testing, Ensuring compliance with 21 CFR Part 11 and GCP, Mapping raw and processed data into CDISC-compliant structures, Compiling and structuring statistical reports for regulatory submissions
