Senior/Principal Biostatistician

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

• Lead the design and data analysis of clinical validation and clinical utility studies on novel next generation sequencing-based diagnostic devices and algorithms for oncology
• Provide key contributions to the analytical and clinical studies in the program, including but not limited to protocol development, statistical analysis plans, and data reporting
• Contribute to the planning and delivery of key analytical or clinical components of regulatory submissions, including but not limited to Q-subs, TAs, PMAs, and sPMAs
• Provide strategic contributions in addressing statistical issues from challenges to the company’s products
• Represent Biostatistics in key regulatory meetings
• Develop innovative and creative statistical and technical solutions to complex problems
• especially as they pertain to retrospective studies
• Maintain statistics quality standards throughout the study process and statistical accuracy in all documents pertaining to the study
• Ensure statistical work is completed in accordance with established timeframes
• Serve as a resource for less experienced Biostatisticians
• Track biostatistics activity deliverables
• Collaborate with data scientists, laboratory scientists, the medical team, technologists and the regulatory team on study design, planning, data preparation, programming, analysis and presentation of results
• Draft study protocols and issue final reports on these studies
• Maintain availability to the wider Tempus business for statistical interpretation and analysis
• Solicit feedback and communicate study results within Tempus and to external stakeholders
• Other duties as assigned

• Master’s Degree with 4+ years of experience as a statistician in FDA, academia or in the biopharmaceutical or diagnostics industry, or 2+ years of experience with a Doctor of Philosophy in Biostatistics, Statistics or a related field
• 8+ years of as a statistician in FDA, academia or in the biopharmaceutical or diagnostics industry
• Computational skills using Python, R, or SAS, especially relevant statistical tools and packages
• Thorough understanding of statistical principles and clinical experiment methodology

• Extensive scientific understanding of cancer genetics and genomics
• Knowledge and experience with Next-Generation Sequencing (NGS)
• Hands-on experience in helping to prepare regulatory submissions
• Strong verbal and written communication skills
• Demonstrated leadership skills including proactive strategy setting, priority evaluations, conflict resolution, and effective partnerships
• Strong programming skills, technical proficiency and creativity
• Demonstrated history of independent thinking
• Excellent communication, presentations and writing skills, and the ability to explain complex technical details in clear language
• Demonstrated ability to meet project deadlines
• Demonstrated record of successful independent work and contributions to team projects
• High level of detail orientation with a focus on quality
• Ability to work well under pressure while maintaining a professional demeanor
• Understanding of HIPAA and importance of privacy of patient data