Biostatistician; Analytical Validation US Remote
Position: Staff Biostatistician (Analytical Validation) New US Remote
Location: Mount Cobb
US Remote
This is an exciting opportunity to independently lead Biostatistics efforts advancing Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics expertise to drive the strategy and execution of complex validation experiments for multiple high‑priority projects. The ideal candidate will possess exceptional communication skills and a deep understanding of Biostatistics in analytical validation.
Primary
Responsibilities
• Strategic Study Design and Analysis
:
Independently lead the design, analysis, and interpretation of analytical validation studies for oncology products.
• Cross‑Functional Leadership
:
Serve as the statistical lead on multiple high‑priority project teams. Partner with bench scientists, bioinformatics, and product development teams to integrate statistical expertise into project planning and execution, identify risks, communicate concerns, and champion solutions to interdisciplinary teams.
• Documentation and Reporting
:
Prepare comprehensive protocols and reports for cross‑functional collaborators and stakeholders.
• Regulatory Compliance
:
Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as CAP/CLIA, NYS, and the FDA.
• Innovation and Improvement
:
Provide leadership on the application of both common and cutting‑edge statistical methods for studies of varying complexity.
Qualifications
• Minimum 8 years of relevant industry experience, with a focus on analytical validation in diagnostics, biotechnology, or related industries.
• Ph.D. or Master’s degree in Biostatistics, Statistics, or a related field.
Knowledge, Skills, and Abilities
• Expert‑level knowledge of statistical methodology in diagnostic medicine, including a deep understanding of CLSI guidelines.
• Exemplary written and verbal communication skills, with a specific talent for presenting to non‑technical executive leadership.
• Demonstrated ability and enthusiasm for working on cross‑functional teams with members of diverse technical backgrounds.
• Exceptional problem‑solving skills and attention to detail.
Our Opportunity
Natera™ is a global leader in cell‑free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world‑class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
What We Offer
• Competitive benefits:
Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401(k) benefits, commuter benefits and much more. A generous employee referral program is also offered.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
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Location: Mount Cobb
US Remote
This is an exciting opportunity to independently lead Biostatistics efforts advancing Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics expertise to drive the strategy and execution of complex validation experiments for multiple high‑priority projects. The ideal candidate will possess exceptional communication skills and a deep understanding of Biostatistics in analytical validation.
Primary
Responsibilities
• Strategic Study Design and Analysis
:
Independently lead the design, analysis, and interpretation of analytical validation studies for oncology products.
• Cross‑Functional Leadership
:
Serve as the statistical lead on multiple high‑priority project teams. Partner with bench scientists, bioinformatics, and product development teams to integrate statistical expertise into project planning and execution, identify risks, communicate concerns, and champion solutions to interdisciplinary teams.
• Documentation and Reporting
:
Prepare comprehensive protocols and reports for cross‑functional collaborators and stakeholders.
• Regulatory Compliance
:
Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as CAP/CLIA, NYS, and the FDA.
• Innovation and Improvement
:
Provide leadership on the application of both common and cutting‑edge statistical methods for studies of varying complexity.
Qualifications
• Minimum 8 years of relevant industry experience, with a focus on analytical validation in diagnostics, biotechnology, or related industries.
• Ph.D. or Master’s degree in Biostatistics, Statistics, or a related field.
Knowledge, Skills, and Abilities
• Expert‑level knowledge of statistical methodology in diagnostic medicine, including a deep understanding of CLSI guidelines.
• Exemplary written and verbal communication skills, with a specific talent for presenting to non‑technical executive leadership.
• Demonstrated ability and enthusiasm for working on cross‑functional teams with members of diverse technical backgrounds.
• Exceptional problem‑solving skills and attention to detail.
Our Opportunity
Natera™ is a global leader in cell‑free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world‑class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
What We Offer
• Competitive benefits:
Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401(k) benefits, commuter benefits and much more. A generous employee referral program is also offered.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
#J-18808-Ljbffr
Apply tot his job
Apply To this Job