Director, Biostatistics (AI)

Location: Chicago, United States

Salary: $180,000–$240,000 USD annually for Chicago; ranges may vary by location.

Company

hirify.global develops an AI-powered precision medicine platform that connects real-world evidence with clinical care to provide actionable treatment insights.

What you will do

• Build and lead a high-performance biostatistics team covering statistical methods, clinical trial design, and data analysis.
• Provide methodological leadership for retrospective validation studies and collaborate with Medical Science, Research, Data Science, laboratory, medical, technology, and regulatory teams.
• Develop statistical analysis plans for interventional and observational studies, including sample size, power calculations, and statistical methodology.
• Lead analytical and clinical components of regulatory submissions, including Q-subs, TAs, PMAs, and sPMAs.
• Represent Biostatistics in regulatory authority interactions and key regulatory meetings.
• Produce detailed project documentation, solve complex analytical problems, and apply novel statistical methods.

Requirements

• Ph.D. in Biostatistics, Statistics, or a related field with 7+ years of relevant industry experience, or a Master's degree with 9+ years.
• Proven experience applying real-world data to clinical research and a thorough understanding of statistical principles and clinical experiment methodology.
• Demonstrated management experience leading Ph.D.- and Master's-level biostatisticians and training junior statisticians.
• Experience collaborating with statistical programmers, clinical operations, data managers, and other clinical research functions.
• Computational skills in R and/or SAS, including relevant statistical tools and packages.
• Ability to manage multiple projects, work independently on complex problems, and present and interpret research results.

Nice to have

• Expertise in time-to-event analysis, oncology or cardiology clinical trials, and claims, EHR, or registry-based real-world data studies.
• Familiarity with machine learning for predictive and prognostic medical research, cancer genetics, immunology, molecular biology, or ECG prediction models.
• Knowledge of FDA regulations, CLIA/CAP validation protocols, version control, software testing, or data science model validation.
• SQL proficiency and client-facing or consulting experience.

Culture & Benefits

• Multidisciplinary collaboration and team-based decision-making.
• Opportunities to work on precision medicine, clinical research, and healthcare analytics.
• Benefits may include incentive compensation, restricted stock units, medical benefits, and other benefits depending on the position.
• Commitment to high-integrity, high-quality, and timely analytical work.