Director of Biostatistics

Responsibilities

• Build, mentor, and direct a high-performing biostatistics team
• Oversee the design, statistical analysis, and interpretation of analytical validation studies for oncology products
• Partner with bench scientists, regulatory, and product development teams
• Prepare high-quality protocols and reports for internal and external stakeholders
• Ensure statistical methodologies meet CAP/CLIA and FDA standards
• Lead statistical interactions with regulatory agencies
• Drive innovation in the application of cutting-edge statistical methods

Requirements

• Minimum of 8 years of industry experience
• At least 5 years of experience in diagnostics
• At least 5 years of experience leading a team
• Master’s degree in statistics, biostatistics, or equivalent (PhD preferred)
• Expert knowledge of statistical methodology in diagnostic devices and FDA guidelines
• Experience interacting with regulatory agencies like the FDA

Preferred Qualifications

• Experience with NGS, genetics, and oncology

Benefits

• Annual performance incentive bonus
• Long-term equity awards
• Comprehensive health benefits (medical, dental, vision)
• 401(k) with company match
• Generous paid time off and company holidays
• Wellness and work-life benefits
• Free testing and fertility care benefits for employees and families

About the Company

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health, aiming to make personalized genetic testing a standard of care.