Staff Biostatistician

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Natera

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Non-Invasive Prenatal Testing (NIPT) • Single gene diseases • Preimplantation Genetic Screening (PGS)/Diagnosis (PGD) • Biopsy training • Multi-Disease Carrier Screening

1001 - 5000 employees

Founded 2004

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Description

• This is an exciting opportunity to advance Natera's regulated product portfolio of cutting-edge molecular diagnostic tests. • As a Staff Biostatistician, you will leverage your strong applied statistics and IVD expertise to oversee the design, analysis, and interpretation of analytical and clinical validation studies for complex biomarkers used in the detection, monitoring, and management of cancer. • Lead Biostatistics efforts designing and executing development, analytical, and clinical studies to support in vitro diagnostic approvals (e.g., IVDR, 510(k), PMA, etc.). • Lead interactions with regulatory authorities. • Lead statistical calculations and analyses for studies of varying complexity. • Promote statistical and regulatory best practices. • Produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation. • Effectively convey statistical concepts and results to cross-functional internal and external collaborators and stakeholders. • Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams. • Stay current with advancements in Biostatistics and analytical/clinical validation methodology, implementing innovative approaches to support product development and regulatory submissions. • Mentor and provide technical supervision to junior team members. • Perform other duties as assigned.

Requirements

• Ph.D. or Master's degree in Biostatistics, Statistics, or a related field. • At least 8 years of experience in Biostatistics, preferably within molecular diagnostics, biotechnology, or related fields. • Demonstrated experience in regulated environments. • Experience evaluating next-generation sequencing (NGS), genetic, and/or oncology-related data. • Minimum of 4 years practical experience with statistical analysis software such as R (preferred), SAS, or JMP.

Benefits

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