Data Scientist - Statistical Programmer (f/m/x)
Core
Statistical Programmer responsible for validating Digital Health Technologies through regulatory-grade programming and statistical analysis plans.
Role type
Senior Statistical Programmer (Clinical Validation)
Builds
Regulatory submission packages and validation documentation for Digital Health Technologies
Domain
Digital Health / Clinical Trials / Regulatory Affairs
Deliverable
production ML models | dashboards & analysis
Required skills
Statistical programming, SAP authoring, Bland-Altman analysis, mixed-effects models, CDISC standards, Python, Git, unit testing
Preferred skills
FDA/EMA submission experience, measurement agreement assessment
Technologies
Python, R, Git
Responsibilities
Designing Statistical Analysis Plans for Clinical Validation, Writing clean, modular, and well-documented code to generate datasets and statistical outputs, Mapping raw and processed DHT data into CDISC-compliant data structures, Compiling and structuring statistical reports and validation documentation for regulatory submissions, Ensuring compliance with regulatory standards including 21 CFR Part 11 and GCP, Selecting and documenting suitable statistical methods and success criteria to meet FDA and EMA validation requirements
Seniority
Senior, hands-on IC
