This is an exciting opportunity to independently lead the Biostatistics effort supporting Natera’s portfolio of cutting-edge technology within our Therapeutics & Innovations business unit. As a Staff Biostatistician, you will leverage your clinical statistics expertise to oversee the design, analysis, and reporting for clinical trials, pre-clinical studies, and associated activities to advance our therapeutic candidates from discovery through clinical development.
The ideal candidate will possess excellent communication skills, an innovative scientific mind, and a deep understanding of biostatistics in a clinical product development setting.
PRIMARY RESPONSIBILITIES:
- Study Design and Analysis: Lead the strategic design, statistical analysis, and interpretation of clinical and pre-clinical development studies, ensuring scientific rigor, regulatory compliance, and ethical standards.
- Cross-Functional Collaboration: Partner with translational, regulatory, clinical, and product development teams to provide statistical expertise for project planning, model evaluation, and execution. Identify risks, communicate concerns, and champion solutions to interdisciplinary teams.
- Documentation and Reporting: Develop and review high-quality protocols, statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders.
- Regulatory Compliance: Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as the FDA.
- Innovation and Improvement: Provide functional leadership on the application of both common and cutting-edge statistical methods for studies of varying complexity and regulatory constraints.
QUALIFICATIONS:
- Minimum 8 years relevant clinical experience, with a focus in oncology, immunology, or related pharmaceutical and biotech industries.
- PhD or Master's degree in Biostatistics, Statistics, or a related field.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Extensive experience with statistical methodologies used throughout the full clinical development lifecycles. Experience with complex study designs, sample size determination, advanced analytical methods, and applicable FDA regulations expected.
- Prior experience with immuno-oncology, therapeutic vaccines, or related precision medicine therapeutic areas required. Experience with NGS, machine learning, and bioinformatics preferred.
- Demonstrated ability and enthusiasm for working on fast-paced 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, strategic innovation, and attention to detail
- Outstanding communication, influencing, and analytical skills. Experience directly interacting with regulatory bodies (FDA, EMA) preferred.
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!
For more information, visit www.natera.com.
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.
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page
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