Lead Biostatistician – Oncology Clinical Studies

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $130.9k - $163.6k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Natera

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Natera is a global leader in cell-free DNA testing technology, specializing in non-invasive genetic testing and diagnostics. The company's innovative solutions focus on areas such as prenatal screening, cancer detection, and organ transplant monitoring. By using advanced bioinformatics and DNA analysis, Natera provides healthcare professionals and patients with critical information to make more informed medical decisions.

📋 Description

• Lead 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 for complex oncology use cases • Serve as study statistician for multiple studies • Collaborate with clinical, medical, and translational partners on study planning, development, and execution • Identify risks, communicate concerns, and champion solutions to interdisciplinary teams and executive leaders • Author and review statistical analysis plans, statistical reports, TLFs, CSRs, and publications • Recommend and apply novel statistical approaches • Mentor early-career statisticians • Support continuous improvement of departmental processes, tools, and templates • Collaborate on publication manuscripts

🎯 Requirements

• 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, including adaptive and biomarker-informed designs, power calculations, and endpoint evaluation • Working knowledge of ICH and GCP guidelines and CDISC standards, including SDTM and ADaM • Proficient in R • Expert-level ability to independently design clinical studies • Experience with biomarker enabled clinical study designs, sample size determination, and endpoint evaluation • Ability to work in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds • Ability to communicate complex statistical concepts clearly to technical and non-technical audiences • Working knowledge of NGS-based diagnostics and ctDNA/MRD preferred • Experience with non-inferiority studies preferred

🏖️ Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents • Free testing for employees and their immediate families • Fertility care benefits • Pregnancy and baby bonding leave • 401k benefits • Commuter benefits • Employee referral program • Equal Opportunity Employer and diverse, inclusive workplace