生物统计学负责人（肿瘤临床研究）
Lead Biostatistician (Oncology Clinical Studies)
这是一个极具挑战性的机会，为一位经验丰富的独立临床生物统计学家提供平台，推动Natera公司肿瘤学产品组合的前沿分子诊断测试的广泛应用。作为首席生物统计学家，您将独立领导多个具有变革意义的肿瘤学临床试验的设计、分析和报告工作。您将提出高效且适用的研究设计，对肿瘤学产品组合产生广泛影响。
理想的候选人具备深厚的统计专业知识、强大的科学沟通能力，并在快节奏、跨职能环境中成功应用创新方法进行肿瘤学临床试验设计的经验。
主要职责：
- 研究设计与统计策略：领导肿瘤学临床实用性研究的统计设计和分析计划。提供复杂研究设计方法和数据分析方面的专业技术支持。提出并证明针对复杂肿瘤应用场景的高效研究设计。
- 跨职能协作：担任多项研究的统计负责人。与临床、医学和转化合作伙伴协作，影响研究规划、开发和执行。识别风险，主动沟通担忧，并向跨学科团队和高管领导倡导解决方案。
- 文件与报告：撰写和审核高质量的统计交付物，包括统计分析计划（SAPs）以及针对跨职能合作者和利益相关者的报告（TLFs、CSRs、出版物）。
- 创新与改进：在适当情况下推荐并应用新颖的统计方法。指导早期职业统计学家，支持部门流程、工具和模板的持续改进，以提高团队效率和分析严谨性。参与论文的撰写合作。
资格要求：
- 生物统计学、统计学或相关定量领域的高级学位（博士优先）。
- 4年以上临床试验生物统计学经验。
- 在生存分析方面有深厚的专业知识，包括处理删失、竞争风险和常用于肿瘤学的高级生存建模方法。
- 熟悉创新研究设计（如自适应设计和生物标志物指导设计）、功效计算和终点评估。
- 了解ICH和GCP指南以及CDISC标准（如SDTM、ADaM）。
- 精通R语言。
查看英文原文
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 Lead Biostatistician, you will independently lead the design, analysis, and reporting for multiple practice-changing oncology clinical trials. You will propose efficient, fit-for-purpose study designs with broad impact across the oncology portfolio.
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 multiple studies. Collaborate with clinical, medical, and translational partners 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).
- 4+ 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.
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
$130,900—$180,000 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!
For more information, visit .
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.
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Originally posted on Himalayas