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Biostatistics
SAS Clinical Programming
Outsourcing
Other Services
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 unblinded analysis
DSMB Statistician
NDA/BLA Pre-Meeting Package preparation
Assist Advisory and Expert Groups with 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