Senior/Principal Biostatistician

Key Skills

AI technology, Effective communication skills, Machine learning techniques, Python Programming, PyTorch, Scikit-learn, SQL, Tableau, TensorFlow

Job Description

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.

We are seeking a highly motivated and capable Principal Biostatistician responsible for (1) providing statistical expertise, and (2) managing the activities for medical diagnostic device analytical/clinical studies to ensure valid and efficient study designs that allow clearly interpretable results and timely delivery of data analyses, study reports, and regulatory documents. The role builds and maintains strong collaborations with other teams across the organization to develop study plans, study protocols, and decision frameworks as well as provides responses to statistical issues arising around the company. The function contributes to the long-term growth strategy of the Market Access, Reimbursement, and Clinical Evidence Development teams by participating in process improvement initiatives and contributing to the development of statistical methodologies applicable to assay and algorithm validation.

Responsibilities

• 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

Qualifications Minimum

• 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

Preferred

• 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