Lead Biostatistician (IVD Clinical)
Core
Oversee the design, analysis, and interpretation of clinical trials for regulatory submissions to support Natera's oncology portfolio of molecular diagnostic tests.
Role type
Lead Biostatistician (IVD Clinical)
Builds
Regulated clinical trial data and documentation for oncology diagnostic products
Domain
Healthcare / Oncology / Molecular Diagnostics
Deliverable
production ML models | dashboards & analysis
Required skills
Applied statistics, clinical trial design, regulatory standards, statistical analysis software (R, SAS, JMP), documentation, risk management, mentoring
Preferred skills
Next-generation sequencing (NGS), genetics, oncology testing, FDA interaction, diagnostic experience
Technologies
R, SAS, JMP
Responsibilities
Design and review statistical methodology in protocols and statistical analysis plans; Lead execution of statistical analyses according to plans and protocols; Produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation; Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams; Mentor and provide technical supervision to junior team members
Seniority
Senior, hands-on IC with mentorship