Staff Biostatistician

Summary

Join Natera's Therapeutics & Innovations business unit as a Staff Biostatistician to lead the biostatistics effort supporting cutting-edge technology. You will leverage your clinical statistics expertise to oversee the design, analysis, and reporting for clinical trials and pre-clinical studies. The ideal candidate will possess excellent communication skills, an innovative scientific mind, and a deep understanding of biostatistics in a clinical product development setting. This role involves cross-functional collaboration with various teams and ensuring regulatory compliance. You will also contribute to innovation and improvement by applying both common and cutting-edge statistical methods. The position offers a competitive salary and benefits package.

Requirements

• Minimum 8 years relevant clinical experience, with a focus in oncology, immunology, or related pharmaceutical and biotech industries
• PhD or Master's degree in Biostatistics, Statistics, or a related field
• Extensive experience with statistical methodologies used throughout the full clinical development lifecycles. Experience with complex study designs, sample size determination, advanced analytical methods, and applicable FDA regulations expected
• Prior experience with immuno-oncology, therapeutic vaccines, or related precision medicine therapeutic areas required
• 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 and pre-clinical development studies, ensuring scientific rigor, regulatory compliance, and ethical standards
• 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

• Experience with NGS, machine learning, and bioinformatics preferred
• Experience directly interacting with regulatory bodies (FDA, EMA) preferred

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!