This Principal Biostatistician position is fully remote and begins on an initial 6-month contract with opportunity for extension or conversion.
As a Principal Biostatistician, you will lead Biostatistics planning activities and guide clinical development programs as well as get the opportunity to work on key neurodegeneration studies.
-Devise and lead statistical strategies for clinical development of Phase II and III studies and NDA/MAA/BLA submissions
-Ensure statistical integrity of analysis and reporting deliverables
-Conduct hands-on exploratory analyses, sample size estimation, modeling and simulation
-Colaborate with Clinical Operations to select, oversee, contract, and manage Biostatistics vendors and contract research organizations
-8+ years industry experience as a Biostatistician
-Extensive knowledge of statistical methodology and its application to solve problems in the pharmaceuticals/biotechnology settings
-Experience supporting regulatory submissions
-Proficient in R, Shiny, and SAS
-Working knowledge of Git and Unix/Linux environments
-Familiarity with industry data standards, including CDISC, SDTM, and ADaM data models
-Ability to work cross functionally and be highly independent