Principal Biostatistician
Core
Lead statistical activities for clinical trials, including protocol design, analysis planning, data analysis, and reporting to regulatory agencies and sponsors.
Role type
Principal Biostatistician (Clinical Trials)
Builds
Statistical analysis plans, analysis datasets, tables, figures, listings, and clinical study reports
Domain
Clinical Research / Biostatistics / Pharma
Required skills
SAS programming, advanced statistical concepts, sample size calculations, adaptive design, ICH guidelines, CDISC data structures, 21 CFR Part 11, FDA guidelines
Preferred skills
Oncology experience, rare diseases experience, late phase submissions, consulting on study design, specific therapeutic area expertise
Technologies
SAS
Responsibilities
Write and review statistical sections of protocols and analysis plans; conduct statistical analyses and present results; develop SAS programs for tables, listings, and figures; generate randomization schedules; perform sample size calculations; review statistical analysis plans written by others; provide statistical support to regulatory agencies; serve as unblinded biostatistician for Data Monitoring Committees; review clinical study reports; lead statistical activities within timelines; supervise other biostatisticians; manage project budgets and invoices.
Seniority
Principal, hands-on IC with mentorship