[Remote] Staff Biostatistician (Analytical Validation)

Note: The job is a remote job and is open to candidates in USA. Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. As a Staff Biostatistician, you will independently lead Biostatistics efforts to advance Natera’s oncology portfolio, driving the strategy and execution of complex validation experiments for multiple high-priority projects.

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

Skills

• 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
• 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

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Natera employees and their immediate families receive free testing in addition to fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• Generous employee referral program

Company Overview

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