Director of Biostatistics

2 days ago

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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

• Lead a team of statisticians working on Natera’s oncology portfolio. • Leverage applied statistics expertise for analytical validation studies. • Ensure compliance with regulatory guidelines and drive data-informed decisions. • Build, mentor, and direct a high-performing biostatistics team. • Oversee study design and statistical analysis for product development. • Collaborate with scientists and regulatory teams to integrate statistical expertise. • Prepare high-quality protocols and reports for internal and external stakeholders. • Ensure methodologies meet regulatory standards set by agencies like CAP/CLIA and FDA. • Lead innovation on applications of statistical methods. • Continuously improve team efficiency and promote departmental standards.

Requirements

• Minimum 10 years of relevant industry experience, with a focus on analytical validation in diagnostics, biotechnology, or related industries. At least 5 years leading a team. • Ph.D. or Master's degree in Biostatistics, Statistics, or a related field. • Proven record of hiring, mentoring, and developing a successful, productive team. • Expert working knowledge of statistical methods in diagnostic medicine, including current CLSI and FDA guidelines. • Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds. • Strong track record of producing high quality written documentation for multiple audiences. • Exceptional problem-solving skills and attention to detail. • Prior experience with NGS, genetics, and/or oncology molecular diagnostic testing a plus.

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. • Natera employees and their immediate families receive free testing in addition to fertility care benefits. • Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. • Generous employee referral program!