Data Scientist - Statistical Programmer (f/m/x)
Core
Authoring Statistical Analysis Plans and executing regulatory-grade programming for the analytical and clinical validation of Digital Health Technologies.
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 Analysis Plans (SAP) authoring, Python for statistical programming, Bland-Altman analysis, mixed-effects models, CDISC standards, FDA/EMA compliance, 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 suitable statistical methods, Writing clean, modular, and well-documented code, Implementing software development best practices, Ensuring compliance with regulatory standards, Mapping raw and processed DHT data into CDISC-compliant data structures
Seniority
Senior, hands-on IC
