Director, Biostatistics

Tempus AI · Vertical AI · Chicago, IL +2

Director of Biostatistics to lead a team in clinical research, focusing on statistical analysis, clinical trial design, and regulatory submissions for a healthcare company leveraging real-world evidence and AI. The role involves collaboration with data scientists and medical teams, and ensuring compliance with regulations.

What you'd actually do

  1. 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
  2. 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.
  3. 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.
  4. Participate actively in interactions with regulatory authorities, supporting Tempus’ regulatory affairs team. Represent Biostatistics in key regulatory meetings.
  5. 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.

Skills

Required

  • Biostatistics
  • Statistics
  • Clinical trial design
  • Data analysis
  • Statistical analysis plan (SAP)
  • Sample size and power calculations
  • Regulatory submissions
  • Real World Data (RWD)
  • R
  • SAS
  • Management skills
  • Team leadership

Nice to have

  • Time to event analysis
  • Oncology clinical trials
  • Cardiology clinical trials
  • Machine learning techniques
  • Predictive and prognostic algorithms
  • Cancer genetics
  • Immunology
  • Molecular biology
  • ECG prediction model
  • FDA regulations
  • CLIA/CAP validation protocols
  • SQL

What the JD emphasized

  • 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
  • Demonstrated management skills
  • Thorough understanding of statistical principles and clinical experiment methodology
  • Comply with all regulations and Company procedures