Director, Biostatistics

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 Director of Biostatistics to lead a team of biostatisticians involved in multiple aspects of clinical research at Tempus. The Director of Biostatistics builds and maintains strong collaborations with other teams across the organization such as Medical Science, Research and Data Science.

Responsibilities:

• Build and lead a high-performance team of biostatisticians with expertise in various aspects of statistics, clinical trial design, and data analysis.
• Provide expert conceptual and methodological leadership and collaborate with stakeholders through the design and conduct of retrospective validation studies
• Lead development on statistical analysis plan (SAP) for Tempus sponsored interventional and observational studies. This will include sample size and power calculations, and propose accurate and efficient statistical methodologies.
• Drive the planning and delivery of key analytical or clinical components of regulatory submissions, including but not limited to Q-subs, TAs, PMAs, and sPMAs.
• Participate actively in interactions with regulatory authorities, supporting Tempus’ regulatory affairs team.
• Represent Biostatistics in key regulatory meetings.
• 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.
• Produce high quality and detailed documentation for all projects in collaboration with other biostatisticians and data scientists.
• Independent work on complex problems, and selecting and adapting novel methods as appropriate
• Stay updated on the latest methodological advances in real world data studies and clinical trials
• Comply with all regulations and Company procedures

Required Experience:

• Ph.D. or Masters Degree in Biostatistics, Statistics, or a related field with 7+ years (Ph.D.) / 9+ years (MS/MA) relevant industry experience.
• Proven experience working with Real World Data and its applications in clinical research.
• You have experience developing SOPs to document departmental processes for biostatistics.
• Demonstrated management skills; ability to manage the work of Ph.D./MS level biostatisticians, and have developed training for junior statisticians new to the industry.
• Experience working with other groups involved in clinical research, such as Statistical Programmers, Clinical Operations, Data Managers, etc.
• Thorough understanding of statistical principles and clinical experiment methodology.
• Computational skills using R, and/or SAS, especially relevant statistical tools and packages.
• Ability to work in a multi-disciplinary team setting and employ a team approach to decision making.
• Able to prioritize and manage several projects simultaneously.

Ideal candidates will possess:

• Extensive knowledge of time to event analysis and methodology
• Experience working in oncology and/or cardiology clinical trials and/or experience with the analysis of RWD studies (e.g. using claims, EHR or registry data sources)
• Familiarity with machine learning techniques and the advantages and disadvantages of different approaches, especially with respect to predictive and prognostic algorithms in medical research
• Experience in cancer genetics, immunology, molecular biology, or ECG prediction model
• Self-driven and works well in interdisciplinary teams
• Collaborative mindset, an eagerness to learn and a high integrity work ethic
• Sharp attention to detail and passion for delivering high quality and timely analytics deliverables
• Able to effectively present research results to study team and other collaborators, including results interpretation and drawing appropriate inferences based on study design/statistical methods as well as assessment of study limitations

Nice to have:

• Working experience and knowledge of FDA regulations and guidelines
• Experience with CLIA/CAP validation protocols and how to bring scientific ideas to market.
• Experience with version control and software testing
• Experience supporting data science teams in model building and validation