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Lead Biostatistician, Analytical Validation
NateraLead Biostatistician leading analytical validation efforts for Natera's oncology portfolio. Collaborating cross-functionally on high-priority projects in molecular diagnostics.
Posted 7/21/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $130,900 - $205,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in statistical methodologies for oncology product validation, with a strong focus on regulatory compliance and cross-functional collaboration. Proven ability to lead analytical validation studies and communicate complex statistical concepts to diverse stakeholders.
Highest-signal resume keywords
Statistical Methodology ExpertiseAnalytical Validation ExperiencePh.D. or Master's Degree in BiostatisticsRegulatory Compliance Knowledge (CAP/CLIA, FDA)Cross-Functional Team Leadership
ATS Keywords
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Hard Skills
Statistical AnalysisAnalytical ValidationBiostatisticsDiagnostic Medicine MethodologiesStatistical Protocol Development
Soft Skills
Written CommunicationVerbal CommunicationProblem-SolvingAttention to DetailTeam Collaboration
Industry Keywords
Oncology ProductsDiagnosticsBiotechnologyCLSI GuidelinesRegulatory Standards
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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!