Staff Biostatistician
Core
Senior technical leader setting statistical vision for clinical study design, conduct, and analysis from feasibility through post-market trials.
Role type
Staff Biostatistician (Individual Contributor)
Builds
Clinical evidence for medical device trials, regulatory submissions, and scientific publications
Domain
Medical Devices / Biostatistics
Deliverable
production ML models | product features | dashboards & analysis | research
Required skills
Biostatistical methodology (adaptive/Bayesian designs), R mastery, SAS/Python, CDISC standards (SDTM/ADaM), regulatory compliance (GCP/ICH), statistical programming standards, version control (Git)
Preferred skills
Surgical/robotic-assisted device experience, AI model application for productivity, external thought leadership
Technologies
R, SAS, Python, Git
Responsibilities
Develop statistical approaches for complex clinical protocols, set standards for Statistical Analysis Plans and mock TLFs, own complex/novel analytical problems, manage 10+ concurrent projects, represent the department with regulatory agencies and KOLs, mentor junior statisticians, lead training curricula and SOP development
Seniority
Staff, hands-on IC with strategic leadership