Lead Biostatistician (IVD Analytical)
Core
Lead biostatistics efforts for designing, analyzing, and interpreting R&D and analytical validation studies for complex biomarkers used in cancer screening, monitoring, and management.
Role type
Lead Biostatistician (IVD Analytical)
Builds
Analytical validation studies supporting CLIA LDT and in vitro diagnostic approvals (IVDR, 510(k), PMA)
Domain
Oncology diagnostics / Molecular diagnostics / Regulated medical devices
Deliverable
production ML models
Required skills
Applied statistics, IVD expertise, Statistical analysis software (R, SAS, JMP), Regulated environment experience, Statistical methodology in diagnostic medicine, CLSI guidelines knowledge
Preferred skills
FDA negotiation experience, Next-generation sequencing (NGS), Genetics, Oncology diagnostics, DNA methylation
Technologies
R, SAS, JMP
Responsibilities
Design and execute analyses for analytical validation studies, Perform statistical analyses (sample size, power, agreement, precision, LoD), Produce documentation of analysis plans and results, Convey statistical concepts to stakeholders, Identify risks and champion solutions, Mentor junior team members
Seniority
Senior, hands-on IC with mentorship responsibilities