Natera

Staff Biostatistician (Analytical Validation)

Natera$180K — $225K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • 8+ years of relevant industry experience in analytical validation for diagnostics or biotechnology.
  • Ph.D. or Master's in Biostatistics, Statistics, or related field.
  • Expert knowledge in statistical methods applied to diagnostic medicine, with strong grasp of CLSI guidelines.
  • Excellent written and verbal communication skills for conveying complex data to non-technical audiences.
  • Proven ability to collaborate on cross-functional teams with diverse technical backgrounds.

Responsibilities

  • Lead the design, analysis, and interpretation of analytical validation studies for oncology products.
  • Serve as the statistical lead on high-priority project teams, collaborating closely with scientists and product developers.
  • Prepare detailed documentation and reports for stakeholders and collaborators.
  • Ensure compliance of statistical methods with regulatory standards like CAP/CLIA and FDA.
  • Drive innovation by applying advanced statistical methods to complex studies.

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.
  • Additional wellness and work-life benefits.
Full Job Description
This is an exciting opportunity to independently lead Biostatistics efforts advancing Natera's oncology portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics expertise to drive the strategy and execution of complex validation experiments for multiple high-priority projects. The ideal candidate will possess exceptional communication skills and a deep understanding of Biostatistics in analytical validation.

PRIMARY RESPONSIBILITIES:
  • Strategic Study Design and Analysis: Independently lead the design, analysis, and interpretation of analytical validation studies for oncology products.
  • Cross-Functional Leadership: Serve as the statistical lead on multiple high-priority project teams. Partner with bench scientists, bioinformatics, and product development teams to integrate statistical expertise into project planning and execution. Identify risks, communicate concerns, and champion solutions to interdisciplinary teams.
  • Documentation and Reporting: Prepare comprehensive protocols and reports for cross-functional collaborators and stakeholders.
  • Regulatory Compliance: Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as CAP/CLIA, NYS, and the FDA.
  • Innovation and Improvement: Provide leadership on the application of both common and cutting-edge statistical methods for studies of varying complexity.

QUALIFICATIONS:
  • Minimum 8 years of relevant industry experience, with a focus on analytical validation in diagnostics, biotechnology, or related industries.
  • Ph.D. or Master's degree in Biostatistics, Statistics, or a related field.

KNOWLEDGE, SKILLS, AND ABILITIES:
  • Expert-level knowledge of statistical methodology in diagnostic medicine, including a deep understanding of CLSI guidelines
  • Exemplary written and verbal communication skills, with a specific talent for presenting to non-technical executive leadership
  • Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds
  • Exceptional problem-solving skills and attention to detail


Compensation & Total Rewards

This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations.

This position is also eligible for additional compensation and benefits through Natera's robust Total Rewards program, including:
  • 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
  • Additional wellness and work-life benefits


Compensation Range

$180,400-$225,500 USD

About Natera

Natera is a biotechnology company that focuses on genetic testing and diagnostics. The company's products are designed to help diagnose and treat genetic diseases, cancer, and other conditions. Natera's pipeline includes products for reproductive health, oncology, and organ transplantation. The company was founded in 2003 and is headquartered in San Carlos, California.
Learn more about Natera
Size
2,670 employees
Market Cap
$4.5 billion
Industry
Net Income
-$229.7 million
Founded
2004
5 Year Trend
+24.1%
Revenue
$391 million
NASDAQ

Similar Jobs

More Jobs at Natera

More Pharmaceuticals & Biotech Jobs

Find similar Staff Biostatistician (Analytical Validation) jobs: