I'm currently sourcing on behalf of a biotech company searching for an experienced Principal Biostatistician. This position would be *fully remote* and begin on an initial 6-month contract with opportunity for extension or direct hire.
Responsibilities:
-Lead statistical strategies for clinical development of drug candidates majorily in Phase II and III studies
-Collaborate with Clinical Operations to select and manage Biostatistics vendors and contract research organizations
-Ensure statistical integrity of analysis and reporting deliverables including endpoint selection, clinical study reports, and optimization of study designs
The ideal candidate would have:
-PhD in Statistics or Biostatistics
-Experience supporting regulatory submissions
-Experience working with orphan indications strongly desired
-Strong programming skills in R, Shiny, Markdown; knowledge of Git and Unix/Linux environments
-Familiarity with industry data standards including CDISC, SDTM, and ADaM data models
