Lead Biostatistician, Analytical Validation

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🏄 California – Remote

🏄 California – Remote

💵 $130.9k - $205k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Natera

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

Natera is a global leader in cell-free DNA testing technology, specializing in non-invasive genetic testing and diagnostics. The company's innovative solutions focus on areas such as prenatal screening, cancer detection, and organ transplant monitoring. By using advanced bioinformatics and DNA analysis, Natera provides healthcare professionals and patients with critical information to make more informed medical decisions.

📋 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 integrate statistical expertise into project planning and execution. • Prepare comprehensive protocols and reports for cross-functional collaborators and stakeholders. • Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as CAP/CLIA, NYS, and the FDA. • Provide leadership on the application of both common and cutting-edge statistical methods for studies of varying complexity.

🎯 Requirements

• Minimum 5 years (Lead) or 8 years (Staff) 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. • Free testing for employees and their immediate families. • Fertility care benefits. • Pregnancy and baby bonding leave. • 401k benefits. • Commuter benefits. • Generous employee referral program!