About the role
Natera is hiring a Staff Biostatistician (Clinical Validation) in San Carlos, CA ($180,400 - $225,500 USD) to advance its regulated molecular diagnostic testing portfolio. The role independently leads the design, analysis, and interpretation of clinical validation studies supporting in vitro diagnostic approvals (including companion diagnostics), ensures statistical compliance with FDA standards and leads regulatory interactions, prepares statistical analysis protocols and reporting materials, serves as statistical lead on cross-functional project teams, and mentors junior staff.
Requirements include a PhD or Master's degree in Biostatistics, Statistics, or a related field; a minimum of 8 years in molecular diagnostics, biotechnology, or regulated environments; prior CDx or IVD submission experience; NGS and germline data experience; and at least 4 years of practical R proficiency. Germline assay development and kidney disease experience are preferred.
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