Staff Biostatistician (Clinical Validation)
Natera
Natera seeks a Staff Biostatistician to lead clinical validation study design, analysis, and interpretation for molecular diagnostic tests. The role requires advanced statistical expertise in regulated diagnostics, regulatory strategy development, and cross-functional project leadership.
Responsibilities
- Lead design, analysis, and interpretation of clinical validation studies for diagnostic approvals
- Ensure statistical methodologies comply with FDA standards and drive regulatory interactions
- Prepare statistical analysis protocols, reports, and presentations for stakeholders
- Serve as statistical lead on high-priority project teams and identify project risks
- Mentor junior team members and stay current with biostatistics advancements
Requirements
- Ph.D. or Master's degree in Biostatistics, Statistics, or related field
- At least 8 years industry experience in molecular diagnostics or biotechnology
- Demonstrated CDx or IVD submission experience in regulated environments
- Experience with next-generation sequencing and germline-related data analysis
- Minimum 4 years practical experience with R statistical software
- Expert knowledge of FDA guidelines and diagnostic statistical methodology
- Prior experience interacting with regulatory bodies such as FDA
Vacancy posted 1 day ago
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