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BIOSTATISTICS

 

   Study design and protocol development

   Sample size calculations

   Statistical Analysis Plan

   Randomization listing

   SAS programming of statistical inferential efficacy tables and figures

   Validation of efficacy and safety summary tables, listings, and figures

   Interim analysis

   Exploratory analysis

   Outcomes research

   Independent Statistician for un-blinded analysis

   DSMB Statistician

   NDA/BLA Pre-Meeting Package preparation

   Assist Advisory and Expert Groups for critical Analyses of Clinical Trials Data

   Assist Medical Writers in writing of Clinical Study Report

   Statistical report writing and abbreviated report writing

   Responses to FDA review questions