Lead Biostatistician – Regulated Diagnostics & NGS Analytics

Natera; San Carlos (CA); On-site; USD 144,000 - 180,000; Full time

Benefits offered by this job

Long-term equity awards

Comprehensive health benefits

401(k) with company match

Paid time off and holidays

Wellness and work-life benefits

Fertility care benefits

Job summary

Natera is seeking a Lead Biostatistician to oversee design, analysis, and interpretation of statistical work for regulated molecular diagnostics used in cancer management. You will lead analytical validation studies supporting CLIA LDT and regulatory submissions, and mentor junior statisticians.

The role emphasizes collaboration with cross-functional teams, clear communication of complex methods, and CLSI-guided practices in a regulated environment.

Qualifications

• Master’s in biostatistics or equivalent with 5+ years of experience, or PhD with 3+ years.
• Previous diagnostic experience.
• Minimum of 4 years practical experience with R, SAS or JMP.
• Experience designing analyses in a regulated environment.

Responsibilities

• Lead biostatistics analyses for analytical validation in CLIA LDT and regulatory submissions.
• Perform sample size, power, agreement, precision, and LoD calculations for validation studies.
• Produce high-quality presentations and documentation of plans, methods, results, and interpretation.
• Explain statistical concepts to cross-functional teams and stakeholders.
• Identify risks and champion solutions within interdisciplinary projects.
• Mentor and supervise junior statisticians.

Skills

Analytical skills

Communication

Cross-functional collaboration

Education

Master’s degree in biostatistics or related field

PhD in biostatistics or related field

Tools

R

SAS

JMP

Job description

Natera is seeking a Lead Biostatistician to oversee design, analysis, and interpretation of statistical work for regulated molecular diagnostics used in cancer management. You will lead analytical validation studies supporting CLIA LDT and regulatory submissions, and mentor junior statisticians.

The role emphasizes collaboration with cross-functional teams, clear communication of complex methods, and CLSI-guided practices in a regulated environment.