Lead Biostatistician – IVD Analytical

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $130.9k - $163.6k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Natera

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Natera is a global leader in cell-free DNA testing technology, specializing in non-invasive genetic testing and diagnostics. The company's innovative solutions focus on areas such as prenatal screening, cancer detection, and organ transplant monitoring. By using advanced bioinformatics and DNA analysis, Natera provides healthcare professionals and patients with critical information to make more informed medical decisions.

📋 Description

• Lead Biostatistics efforts designing and executing analyses for analytical validation studies supporting CLIA LDT and in vitro diagnostic approvals, including IVDR, 510(k), and PMA • Perform statistical analyses including sample size, power, agreement, precision, and LoD calculations for validation studies • Produce presentations and author documentation of analysis plans, methods, results, and interpretation • 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 • Mentor and provide technical supervision to junior team members

🎯 Requirements

• Master’s degree in biostatistics, statistics, or equivalent with 5+ years of relevant experience, or PhD in biostatistics, statistics, or equivalent with 3+ years of relevant experience • Previous diagnostic experience • Minimum of 4 years practical experience with statistical analysis software such as R (required) and SAS or JMP • Experience designing and executing statistical analyses in a regulated environment • Expert working knowledge of statistical methodology in diagnostic medicine, including an understanding of CLSI guidelines • Ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds • Strong communication skills, with the ability to explain complex statistical concepts to non-statistical audiences • Strong track record of producing high quality written documentation for multiple audiences • Prior experience with next-generation sequencing (NGS), genetics, and/or oncology diagnostics • Familiarity with DNA methylation a plus • Experience negotiating with the FDA a plus

🏖️ Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents • Free testing for employees and their immediate families • Fertility care benefits • Pregnancy and baby bonding leave • 401k benefits • Commuter benefits • Employee referral program

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