Principal Biostatistician

Embedded Shishya; United States; Remote; USD 160,000 - 200,000; Full time

Job summary

Natera is seeking a Principal Biostatistician to independently lead the design, analysis, and reporting for oncology randomized trials. You will mentor junior statisticians, champion innovative methodologies, and collaborate across clinical, medical, and translational teams to move practice-changing tests forward.

You will use deep expertise in time-to-event analyses, adaptive designs, and biomarker-informed approaches to shape study strategies, SAPs, and CSRs in a fast-paced environment.

Qualifications

• Advanced degree in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred).
• 15+ years of experience in clinical trial biostatistics.
• Strong expertise in time-to-event analysis, including handling of censoring, competing risks, and advanced survival modeling approaches commonly used in oncology.
• Expertise with innovative study design (e.g. adaptive and biomarker-informed designs), power calculations, and endpoint evaluation.
• Working knowledge of ICH and GCP guidelines as well as CDISC standards (e.g. SDTM, ADaM).
• Proficient in R.

Responsibilities

• Lead the statistical design and analytical planning for oncology clinical utility studies. Propose and justify efficient study designs tailored to complex oncology use cases.
• Serve as study statistician for Natera sponsored studies and provide consults for external collaborations. Partner with clinical, medical, and translational scientists to influence study planning, development, and execution.
• Author and review high-quality statistical deliverables, including SAPs and reports for cross-functional collaborators and stakeholders.
• Recommend and apply novel statistical approaches where appropriate. Mentor early career statisticians and support continuous improvement of departmental processes.

Skills

Time-to-event analysis

R proficiency

Biostatistics expertise

Cross-functional collaboration

Biomarker study design

Education

PhD preferred

Tools

CDISC SDTM/ADaM

Job description

This is an exciting opportunity for a highly experienced, independent clinical biostatistician to advance adoption of Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Principal Biostatistician, you will independently lead the design, analysis, and reporting for practice-changing oncology randomized control clinical trials. You will propose efficient, fit-for-purpose study designs with broad impact across the oncology portfolio. You will serve as a mentor for junior members of the team and identify and explore methodological areas for innovation.

The ideal candidate brings deep statistical expertise, strong scientific communication skills, and a proven track record of applying innovative methodologies to oncology clinical trial design in a fast-paced, cross-functional environment.

PRIMARY RESPONSIBILITIES:

• Study Design and Statistical Strategy: Lead the statistical design and analytical planning for oncology clinical utility studies. Provide technical expertise in complex study design methodologies and data analyses. Propose and justify efficient study designs tailored to complex oncology use cases.
• Cross-Functional Collaboration: Serve as study statistician for Natera sponsored studies and provide consults for external collaborations. Partner with clinical, medical, and translational scientists to influence study planning, development, and execution. Identify risks, proactively communicate concerns, and champion solutions to interdisciplinary teams and executive leaders.
• Documentation and Reporting: Author and review high-quality statistical deliverables, including statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders.
• Innovation and Improvement: Recommend and apply novel statistical approaches where appropriate. Mentor early career statisticians and support continuous improvement of departmental processes, tools, and templates to enhance team efficiency and analytical rigor. Collaborate on manuscripts for publications.

QUALIFICATIONS:

• Advanced degree in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred).
• 15+ years of experience in clinical trial biostatistics.
• Strong expertise in time-to-event analysis, including handling of censoring, competing risks, and advanced survival modeling approaches commonly used in oncology.
• Expertise with innovative study design (e.g. adaptive and biomarker-informed designs), power calculations, and endpoint evaluation.
• Working knowledge of ICH and GCP guidelines as well as CDISC standards (e.g. SDTM, ADaM).
• Proficient in R.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Expert-level ability to independently design clinical studies, grounded in deep domain knowledge and a nuanced understanding of complex, oncology-specific challenges.
• Experience with biomarker enabled clinical study designs, sample size determination, and endpoint evaluation.
• Demonstrated ability and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds.
• Ability to communicate complex statistical concepts clearly to both technical and non-technical audiences.
• Preferred qualifications:
  • Working-knowledge of NGS-based diagnostics and ctDNA/MRD.
  • Experience with non-inferiority studies.

Remote USA

$160,000—$200,000 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.

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/