Source description
About the role
Analytical Validation & Regulatory Execution
Design and develop computational approaches for characterizing the performance of existing and new epigenomic tests.
Define and implement metrics and analyses to assess NGS and epigenomic data quality to enable coordinated optimization of assay and diagnostic performance.
Lead the computational execution of verification and validation protocols, statistical analysis plans (SAPs), and performance summary reports to meet FDA evidentiary standards.
Translate complex computational results into clear, well-organized regulatory documentation for FDA submissions.
Stay current on FDA guidance for IVDs, companion diagnostics, and evolving LDT oversight to actively inform study design decisions.
Statistical & Bioinformatics Analysis
Develop and apply statistical methods for diagnostic characterization, including LOD/LOQ, reproducibility, thresholding, gaurdbanding, and clinical utility endpoints.
Support and optimize robust, reproducible analysis pipelines—ensuring code traceability and standardization from raw NGS data through regulatory-grade outputs.
Identify and systematically address sources of variability, bias, and technical confounding across the computational workflow.
Cross-Functional Collaboration
Partner closely with laboratory development, clinical operations, and regulatory affairs to ensure absolute scientific and regulatory alignment across programs.
Contribute to clinical study design—including sample size calculations, endpoint selection, and pre-specified SAPs using data-driven insights from analytical validation pilots.