Staff Biostatistician – Analytical Validation

Natera; Deutschland; Vor Ort; EUR 140.977 - 176.222; Vollzeit

Benefits dieser Stelle

Comprehensive medical, dental, vision, life and disability plans

Free genetic testing for employees and dependents

401k benefits

Employee referral program

Zusammenfassung

Dormont Manufacturing Co is seeking a Staff Biostatistician to lead Biostatistics efforts advancing its oncology portfolio. You will leverage your applied statistics expertise for validation experiments across high-priority projects.

The ideal candidate will have 8+ years of industry experience, a Ph.D. or Master’s in Biostatistics, and exemplary communication skills. Join us to be at the forefront of innovative diagnostics.

Qualifikationen

• Minimum 8 years of relevant industry experience, focused on analytical validation.
• Strong understanding of CLSI guidelines.

Aufgaben

• Lead the design and analysis of validation studies for oncology products.
• Serve as statistical lead on cross-functional project teams.
• Prepare protocols and reports for stakeholders.
• Ensure compliance with regulatory standards.
• Apply innovative statistical methods for complex studies.

Kenntnisse

Expert-level knowledge of statistical methodology in diagnostic medicine

Exceptional problem-solving skills

Written and verbal communication skills

Ability to work on cross-functional teams

Ausbildung

Ph.D. or Master’s degree in Biostatistics, Statistics, or a related field

Jobbeschreibung

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

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.

Remote USA

$164,000—$205,000 USD

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, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

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.