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Staff Biostatistician (Analytical Validation)

1 month, 2 weeks ago
United States
Full-time
Lead
Data Scientist
Data Science and Analytics
Statistics
Apply Now
Natera

Natera

Natera specializes in cell-free DNA testing, providing advanced genetic testing services for oncology, women's health, and organ health to help families diagnose and manage genetic diseases.

Pharmaceuticals
1K-5K
Founded 2004
View All Jobs 79

Description

  • Independently lead the design, analysis, and interpretation of analytical validation studies for oncology products.
  • Serve as the statistical lead on multiple high-priority project teams.
  • Partner with bench scientists, bioinformatics, and product development teams to support project planning and execution.
  • Identify statistical and project risks, communicate concerns, and help drive solutions across interdisciplinary teams.
  • Prepare comprehensive protocols and reports for cross-functional collaborators and stakeholders.
  • Ensure statistical methods and analyses meet CAP/CLIA, NYS, and FDA standards.
  • Apply both common and cutting-edge statistical methods to studies of varying complexity.
  • Provide statistical leadership to support validation experiments for multiple high-priority projects.

Requirements

  • Minimum 8 years of relevant industry experience in analytical validation within diagnostics, biotechnology, or related industries.
  • Ph.D. or Master’s degree in Biostatistics, Statistics, or a related field.
  • Expert-level knowledge of statistical methodology in diagnostic medicine.
  • Deep understanding of CLSI guidelines.
  • Excellent written and verbal communication skills, including the ability to present to non-technical executive leadership.
  • Demonstrated ability and enthusiasm for working on cross-functional teams with diverse technical backgrounds.
  • Exceptional problem-solving skills and strong attention to detail.
  • Experience with analytical validation in diagnostics is required; experience in biotechnology or related industries is acceptable.
  • Familiarity with regulatory environments such as CAP/CLIA, NYS, and FDA is preferred.

Benefits

  • Annual performance incentive bonus.
  • Long-term equity awards.
  • Comprehensive health benefits, including medical, dental, and vision coverage.
  • 401(k) plan with company match.
  • Generous paid time off and company holidays.
  • Additional wellness and work-life benefits.
  • Life and disability plans for eligible employees and dependents.
  • Free testing for employees and their immediate families, plus fertility care benefits.
  • Pregnancy and baby bonding leave.
  • Commuter benefits and a generous employee referral program.

Interested in this position?

Apply directly on the company website

Apply Now

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