Staff Biostatistician (Clinical Validation)
Core
Lead the design, analysis, and interpretation of clinical validation studies to support in vitro diagnostic (IVD) approvals for kidney disease and germline projects.
Role type
Staff Biostatistician (Clinical Validation)
Builds
Regulated molecular diagnostic tests (CDx, 510(k), PMA)
Domain
Molecular diagnostics / Genetic testing / Kidney disease
Deliverable
production ML models
Required skills
Applied statistics, IVD regulatory standards, Clinical research design, Next-generation sequencing (NGS), R statistical analysis, FDA guidelines, Statistical analysis protocols (SAPs), Cross-functional leadership, Technical supervision
Preferred skills
Germline assay development, Kidney disease experience
Technologies
R, NGS
Responsibilities
Lead design and analysis of clinical validation studies; Ensure statistical methodologies meet FDA standards; Prepare statistical analysis protocols and reports; Serve as statistical lead on project teams; Drive design of clinical trials and publications; Mentor junior team members
Seniority
Staff, hands-on IC with mentorship