Lead Biostatistician (IVD Clinical)

Natera is seeking an experienced Lead Biostatistician specializing in in vitro diagnostic (IVD) clinical development for a full-time position in the United States. As a senior statistical leader, you will direct statistical strategy and execution for clinical studies supporting regulatory submissions across our oncology diagnostic portfolio.

What This Role Involves

You will serve as the principal statistical strategist on cross-functional clinical development teams, overseeing how data is collected, analyzed, and presented to regulatory agencies and clinical collaborators. Your responsibility is translating complex statistical concepts into clear, actionable insights for colleagues across research, clinical operations, and regulatory functions. This role combines deep technical mastery with hands-on leadership of the biostatistics team.

What You'll Do

• Architect statistical methods supporting study protocols and analysis plans
• Direct execution of confirmatory, exploratory, and post-hoc statistical analyses according to protocol specifications
• Author regulatory-quality documentation of analysis approaches, results, and clinical interpretation
• Present statistical findings and methods to internal teams, external partners, and regulatory reviewers
• Identify analytical challenges and champion solutions across cross-functional project teams
• Mentor and supervise biostatistics staff members
• Support additional responsibilities as business needs evolve

Who We're Looking For

• Master's degree in biostatistics or statistics with 5+ years in regulated clinical or diagnostic environments, or PhD in biostatistics or statistics with 3+ years of comparable experience
• Minimum 3 years designing and executing statistical analyses for regulated clinical trials and regulatory submissions
• At least 4 years of hands-on experience with statistical computing platforms (R strongly preferred; SAS or JMP also acceptable)
• Prior practical experience in diagnostic development or clinical laboratory testing
• Expert knowledge of probability theory and advanced statistical methods; ability to develop or adapt novel approaches
• Solid understanding of clinical trial design, regulatory standards, and FDA guidance for diagnostic product submissions
• Demonstrated ability to collaborate effectively with teams spanning diverse scientific and business disciplines
• Strong written and verbal communication skills, with a proven track record of producing clear, well-organized documentation for varied audiences
• Background in next-generation sequencing, genetics, or oncology diagnostics (valued, not required)
• Prior direct engagement with regulatory agencies such as the FDA (valued, not required)

More About Natera

Natera is the leading provider of cell-free DNA testing for oncology, women's health, and organ transplant monitoring. Our mission is to establish genetic testing and molecular diagnostics as standard clinical care, enabling earlier interventions and better patient outcomes. Our team brings together biostatisticians, geneticists, physicians, laboratory directors, and engineers from world-class institutions. The salary range for this position is $130,900–$163,600 USD annually. We offer comprehensive medical, dental, vision, life, and disability insurance; free genetic testing for employees and their families; fertility assistance benefits; paid pregnancy and bonding leave; 401(k) contributions; commuter programs; and an employee referral bonus program.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.