Senior Director of Biostatistics

Summary

Join Natera as a Senior Director of Biostatistics and lead a team of statisticians advancing the company's oncology portfolio. You will leverage your clinical statistics expertise to oversee the strategic design, analysis, and reporting for multiple oncology clinical trials. The ideal candidate possesses exceptional leadership and communication skills, a strong scientific background, and a comprehensive understanding of clinical biostatistics in oncology. Responsibilities include team leadership, study design and analysis, cross-functional collaboration, documentation and reporting, regulatory compliance, innovation and improvement, and strategic leadership. A minimum of 13 years of relevant clinical experience in oncology within the pharmaceutical or biotech industries, including at least 8 years of team leadership, is required. A Ph.D. or Master's degree in Biostatistics, Statistics, or a related field is also necessary.

Requirements

• Minimum 13 years relevant clinical experience, with a focus in oncology in pharmaceutical or related biotech industries
• At least 8 years leading a team
• Ph.D. or Master's degree in Biostatistics, Statistics, or a related field
• Proven track record of hiring, mentoring, and developing high-performing teams of statisticians
• Expert-level ability to independently design clinical studies, grounded in deep domain knowledge and a nuanced understanding of complex, oncology-specific challenges
• Extensive experience with interventional, multi-faceted clinical study designs, sample size determination, and advanced analytical methods
• Demonstrated ability and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds
• Skilled in producing high quality written documentation tailored to a range of audiences
• Exceptional problem-solving skills, strategic innovation, and attention to detail
• Outstanding communication, influencing, and analytical skills across all levels of an organization

Responsibilities

• Build, mentor, and direct a high-performing clinical biostatistics team
• Foster collaboration, and oversee both the technical and professional development of team members
• Lead the strategic planning, statistical analysis, and interpretation of interventional clinical studies
• Partner with medical, clinical, translational, and regulatory teams to apply statistical expertise in study planning, development, and execution
• Identify risks, proactively communicate concerns, and champion solutions to interdisciplinary teams and executive leaders
• Author and review high-quality statistical deliverables, including protocols, statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders
• Ensure statistical methodologies and analyses adhere to applicable regulator standards set by regulatory agencies such as the FDA
• Provide strategic direction on the use of both established and emerging statistical methodologies, adapting approaches to match study complexity and regulatory context
• Drive continuous improvement in team efficiency and analytical rigor
• Promote departmental standards for statistical analysis and ensure alignment with broader organizational and regulatory objectives

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Free testing in addition to fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• A generous employee referral program