Remote Staff Biostatistician — Diagnostic Validation & CDx

Natera; United States; Remote; USD 164,000 - 205,000; Full time

Job summary

Natera is seeking a Staff Biostatistician to drive the strategy, design, analysis, and interpretation of clinical validation studies for kidney disease and other priority projects.

As a statistical lead, you will collaborate with Clinical Science, Data Management, and Product teams, ensuring FDA-ready methodologies and rigorous analyses for regulatory submissions, while mentoring junior staff and delivering high-quality results.

Qualifications

• Ph.D. or Master’s degree in Biostatistics or related field.
• 8+ years of relevant industry experience in molecular diagnostics/biotech.
• Experience in regulated environments with CDx/IVD submissions.
• Experience with NGS/genetic or germline data.
• Strong statistical analysis skills using R.

Responsibilities

• Lead design, analysis, and interpretation of clinical validation studies for regulatory approvals.
• Ensure statistics meet FDA standards and drive regulatory interactions.
• Prepare SAPs, reports, and presentations for cross-functional/external stakeholders.
• Mentor junior team members and lead cross-functional project teams.

Skills

Biostatistics

Clinical validation

R (statistics)

Regulatory submission

NGS/genomics data

FDA interactions

Project leadership

Education

Ph.D. in Biostatistics

Job description

Natera is seeking a Staff Biostatistician to drive the strategy, design, analysis, and interpretation of clinical validation studies for kidney disease and other priority projects.

As a statistical lead, you will collaborate with Clinical Science, Data Management, and Product teams, ensuring FDA-ready methodologies and rigorous analyses for regulatory submissions, while mentoring junior staff and delivering high-quality results.