Lead Biostatistician (Oncology Clinical Studies)

Role: Lead Biostatistician responsible for designing, analyzing, and reporting oncology clinical utility studies within Natera’s molecular diagnostic portfolio. Objectives include proposing innovative, efficient study designs, providing technical expertise in complex statistical methodologies, and influencing clinical trial planning. Responsibilities involve serving as study statistician across multiple projects, collaborating with clinical and translational teams, authoring statistical analysis plans and regulatory reports, and mentoring junior statisticians. Qualifications include a Ph.D. in Biostatistics or related field, at least 4 years of clinical trial biostatistics experience, with expertise in survival analysis, adaptive design, and biomarker-based studies, especially in oncology. Proficiency in R and knowledge of GxP, ICH, GCP, and CDISC standards are required. Preferred skills encompass familiarity with NGS diagnostics, ctDNA/MRD, and non-inferiority trial designs. High-value specifics include focus on cancer diagnostics, liquid biopsy modalities, and clinical utility validation. The role involves cross-functional collaboration across scientific, clinical, and regulatory teams. Work is remote within the USA, with no travel specified.