Remote Lead Biostatistician — Clinical Validation

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

Benefits offered by this job

US Remote

Competitive benefits

Equal Opportunity Employer

Job summary

Natera, Inc. in the United States is seeking an experienced biostatistician to independently lead the design, analysis, and interpretation of clinical validation studies that support in vitro diagnostic approvals (CDx, 510(k), PMA).

The role emphasizes regulatory-compliant methods and collaboration across clinical science, data management and product teams. You will prepare SAPs and reports, mentor junior statisticians, and drive high-impact research and regulatory submissions while staying

Qualifications

• Ph.D. or Master’s in Biostatistics required.
• 8+ years of biostatistics experience; CDx/IVD preferred.
• Experience with regulated environments and regulatory submissions (FDA).

Responsibilities

• Lead design, analysis, and interpretation of clinical validation studies for CDx/IVD approvals.
• Ensure regulatory-compliant statistical methodologies and analyses (FDA expectations).
• Prepare SAPs, reports, and presentations for cross-functional/external collaborators.
• Act as statistical lead on high-priority projects; partner with Clinical Science, Data Management and Product teams.
• Drive design and execution of clinical validation studies and publications.
• Mentor junior statisticians and provide technical supervision.

Skills

FDA guidelines

Cross-functional leadership

Clinical trial design

R statistical analysis

Regulatory submissions

Education

Ph.D. or Master's in Biostatistics

Tools

R

Job description

Natera, Inc. in the United States is seeking an experienced biostatistician to independently lead the design, analysis, and interpretation of clinical validation studies that support in vitro diagnostic approvals (CDx, 510(k), PMA).

The role emphasizes regulatory-compliant methods and collaboration across clinical science, data management and product teams. You will prepare SAPs and reports, mentor junior statisticians, and drive high-impact research and regulatory submissions while staying