Natera's ctDNA diagnostic portfolio needs a Staff Biostatistician to lead the design, analysis, and reporting for oncology clinical trials, aiming to develop practice-changing diagnostics and improve patient health outcomes.
Requirements
- 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 multi-faceted clinical study designs, sample size determination, and advanced analytical methods.
- Working-knowledge of NGS-based diagnostics, ctDNA/MRD, or related biomarkers preferred.
Responsibilities
- Lead the statistical design and analytical planning for oncology clinical utility studies.
- Provide technical expertise in complex study design methodologies and data analyses.
- Author and review high-quality statistical deliverables, including protocols, statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders.
- Recommend and apply novel statistical approaches where appropriate.
- Support continuous improvement of departmental processes, tools, and templates to enhance team efficiency and analytical rigor.
- Independently lead the design, analysis, and reporting for multiple practice-changing oncology clinical trials.
- Apply advanced methodologies in oncology clinical trials.
Other
- Minimum 8 years relevant clinical experience, including work in oncology, diagnostics, or related pharmaceutical/biotech industries.
- Ph.D. or Master's degree in Biostatistics, Statistics, or a related field.
- Serve as the primary statistical representative on study teams.
- 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.
- Demonstrated ability and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds
- Ability to translate complex statistical results into clear, actionable insights for non-statistical audiences
