Director, Biostatistics
Core
Lead a team of biostatisticians to design, plan, and analyze clinical trials and real-world data studies for precision medicine and oncology/cardiology research.
Role type
Director of Biostatistics (hands-on IC with management)
Builds
Regulatory submissions (Q-subs, TAs, PMAs), statistical analysis plans, and clinical research insights for physicians.
Domain
Healthcare / Biostatistics / Clinical Trials / Real-World Data
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
Biostatistics, clinical trial design, real-world data analysis, regulatory submission planning, team leadership, R, SAS, time-to-event analysis, SOP development
Preferred skills
Oncology/cardiology clinical trials, machine learning techniques, cancer genetics, immunology, molecular biology, ECG prediction models, SQL, FDA regulations, CLIA/CAP validation
Technologies
R, SAS, SQL
Responsibilities
Build and lead a high-performance team of biostatisticians; Lead development of statistical analysis plans (SAP) including sample size and power calculations; Drive planning and delivery of regulatory submissions; Participate in interactions with regulatory authorities; Collaborate on study design, planning, data preparation, programming, and analysis; Produce high-quality documentation for projects.
Seniority
Director, strategic leadership with hands-on technical execution
