Lead Biostatistician (Oncology Clinical Studies)

This is an exciting opportunity for a highly experienced, independent clinical biostatistician to advance adoption of Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will independently lead the design, analysis, and reporting for multiple practice-changing oncology clinical trials. You will propose efficient, fit-for-purpose study designs with broad impact across the oncology portfolio.

The ideal candidate brings deep statistical expertise, strong scientific communication skills, and a proven track record of applying innovative methodologies to oncology clinical trial design in a fast-paced, cross-functional environment.

PRIMARY RESPONSIBILITIES: 

• Study Design and Statistical Strategy: Lead the statistical design and analytical planning for oncology clinical utility studies. Provide technical expertise in complex study design methodologies and data analyses. Propose and justify efficient study designs tailored to complex oncology use cases.
• Cross-Functional Collaboration: Serve as study statistician for multiple studies. Collaborate with clinical, medical, and translational partners to influence study planning, development, and execution. Identify risks, proactively communicate concerns, and champion solutions to interdisciplinary teams and executive leaders.
• Documentation and Reporting: Author and review high-quality statistical deliverables, including statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders. 
• Innovation and Improvement: Recommend and apply novel statistical approaches where appropriate. Mentor early career statisticians and support continuous improvement of departmental processes, tools, and templates to enhance team efficiency and analytical rigor.  Collaborate on manuscripts for publications.

QUALIFICATIONS: 

• Advanced degree in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred).
• 4+ years of experience in clinical trial biostatistics.
• Strong expertise in time-to-event analysis, including handling of censoring, competing risks, and advanced survival modeling approaches commonly used in oncology.
• Expertise with innovative study design (e.g. adaptive and biomarker-informed designs), power calculations, and endpoint evaluation.
• Working knowledge of ICH and GCP guidelines as well as CDISC standards (e.g. SDTM, ADaM).
• Proficient in R.

KNOWLEDGE, SKILLS, AND ABILITIES: 

• Expert-level ability to independently design clinical studies, grounded in deep domain knowledge and a nuanced understanding of complex, oncology-specific challenges.
• Experience with biomarker enabled clinical study designs, sample size determination, and endpoint evaluation.
• Demonstrated ability and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds.
• Ability to communicate complex statistical concepts clearly to both technical and non-technical audiences.
• Preferred qualifications: 
  • Working-knowledge of NGS-based diagnostics and ctDNA/MRD.
  • Experience with non-inferiority studies.