Lead Biostatistician

Summary

Join Natera as a Lead Biostatistician to lead biostatistics efforts supporting the company's molecular diagnostic tests. You will oversee the design, analysis, and regulatory submissions for the oncology portfolio. Responsibilities include providing technical leadership in clinical trials, performing statistical analyses, designing statistical methodologies, and producing high-quality documentation. The ideal candidate will have a Master's or PhD in biostatistics with relevant experience in a regulated environment and clinical trials. Strong statistical software skills (R, SAS, or Python) are required. Natera offers competitive benefits, including comprehensive medical, dental, vision, life, and disability plans, as well as free testing for employees and their families.

Requirements

• Master’s degree in biostatistics, statistics, or equivalent with 6+ years of relevant experience, or PhD in biostatistics, statistics, or equivalent with 3+ years of relevant experience
• At least 2 years practical experience designing and executing statistical analyses in a regulated environment and clinical trials for regulatory submissions such as FDA
• Minimum of 4 years practical experience with statistical analysis software such as R (preferred), SAS, or Python
• Expert knowledge of probability theory and statistics including the ability to produce novel methods based on first principles understanding
• Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds
• Familiarity with typical approaches, best practices, and regulatory standards in clinical trial design
• Ability to produce high quality written documentation for varying audiences
• Ability to work independently while managing multiple objectives and timelines
• Desire to work in a fast-paced environment with potential for high impact in a small team

Responsibilities

• Provide technical leadership in the design and execution of all phases of clinical trials
• Perform relevant statistical analyses (e.g., sample size, power, survival, sensitivity, specificity)
• Design and review statistical methodology in statistical analysis plans and protocols
• Execute statistical analyses according to plans and protocols, as well as exploratory or ad-hoc analyses
• Produce high quality written documentation including study protocols, statistical analysis plans and reports, and regulatory submissions
• Effectively convey statistical concepts and results to cross-functional internal and external collaborators and stakeholders
• Promote statistical best practices
• Act as an internal statistical consultant to other functional groups or their members by providing expert advice on statistical methodology
• Perform other duties as assigned

Preferred Qualifications

• Previous diagnostic experience
• Familiarity with Regulatory submissions

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
• A generous employee referral program