Director, Biostatistics — Real-World Data

Tempus AI, Inc.

Chicago (IL)

On-site

USD 180,000 - 260,000

Full time

14 days+
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Job summary

Tempus AI, Inc. seeks a Director of Biostatistics to lead a high‑performing team of biostatisticians across retrospective and prospective clinical studies, with emphasis on real‑world data insights and regulatory submissions.

You will design studies, develop SAPs, and guide analytic plans while collaborating with Medical Science, Data Science and Regulatory Affairs to ensure robust results. The ideal candidate holds a PhD or related Master’s, 7–9+ years of industry experience, and strong

Qualifications

  • Ph.D. or Master's in Biostatistics or related field with substantial industry experience.
  • Proven experience working with Real World Data in clinical research.
  • Experience documenting SOPs for biostatistics processes.
  • Strong leadership and training abilities for junior statisticians.
  • Experience collaborating with cross-functional groups in clinical research.

Responsibilities

  • Build and lead a high-performance team of biostatisticians with expertise in statistics, trial design, and data analysis.
  • Provide methodological leadership and collaborate on retrospective validation studies.
  • Lead SAP development for Tempus sponsored studies including sample size and power calculations.
  • Drive planning and delivery of regulatory submission components (Q-subs, PMAs, sPMAs).
  • Interact with regulatory authorities and support regulatory affairs teams.
  • Represent Biostatistics in key regulatory meetings.
  • Collaborate across data science, medical, and regulatory teams on study design and analysis.
  • Produce high-quality documentation for projects with colleagues.

Skills

Leadership
Real World Data
Regulatory affairs
SOP development
R programming
SAS
Statistical analysis
Clinical trial design

Education

PhD in Biostatistics or related field
MS in Biostatistics or related field

Tools

R
SAS

Job description

Tempus AI, Inc. seeks a Director of Biostatistics to lead a high‑performing team of biostatisticians across retrospective and prospective clinical studies, with emphasis on real‑world data insights and regulatory submissions.

You will design studies, develop SAPs, and guide analytic plans while collaborating with Medical Science, Data Science and Regulatory Affairs to ensure robust results. The ideal candidate holds a PhD or related Master’s, 7–9+ years of industry experience, and strong

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