Staff Biostatistician

Summary

Join Natera as a Staff Biostatistician and lead the biostatistics effort, advancing our cutting-edge technology portfolio. You will leverage your clinical statistics expertise to oversee the design, analysis, and reporting for high-priority projects and Phase I-III clinical trials focused on personalized cancer treatments. This role requires strong communication skills, an innovative mindset, and a deep understanding of biostatistics in clinical product development. You will collaborate with cross-functional teams, ensuring regulatory compliance and contributing to the development of high-quality documentation. The position offers the opportunity to apply both common and cutting-edge statistical methods to studies of varying complexity. Natera is a global leader in cell-free DNA testing, committed to providing personalized genetic testing and diagnostics.

Requirements

• Minimum 8 years relevant clinical experience, with a focus in oncology, immunology, or related pharmaceutical and biotech industries
• Ph.D. or Master's degree in Biostatistics, Statistics, or a related field
• Extensive experience with statistical methodologies throughout the full clinical development lifecycle, including preclinical evaluation, Phase I-III studies, and regulatory approval. Experience with complex study designs, sample size determination, advanced analytical methods, and FDA submission guidelines expected
• Demonstrated ability and enthusiasm for working on fast-paced cross-functional teams with members of diverse technical backgrounds
• Strong track record of producing high quality written documentation for multiple audiences
• Exceptional problem-solving skills, strategic innovation, and attention to detail
• Outstanding communication, influencing, and analytical skills

Responsibilities

• Lead the strategic design, statistical analysis, and interpretation of clinical studies supporting product development
• Partner with translational, regulatory, clinical, and product development teams to provide statistical expertise for project planning, model evaluation, and execution. Identify risks, communicate concerns, and champion solutions to interdisciplinary teams
• Develop and review high-quality protocols, statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders
• Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as the FDA
• Provide functional leadership on the application of both common and cutting-edge statistical methods for studies of varying complexity and regulatory constraints

Preferred Qualifications

Prior experience with NGS, machine learning, bioinformatics, immunology, and/or oncology

Benefits

• Employee benefits include 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
• Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more
• We also offer a generous employee referral program!