Biostatistics

The Algorithme Pharma biostatistic department is involved in the whole process: protocol development, optimal design selection, cost analysis, sample size determination, statistical analysis, as well as final report submission and analysis of its implications on future studies.

Protocol Preparation:

·Groundwork on the statistical aspects of the clinical protocol: development of study designs, sample size calculations and statistical power determination
·Formulation of the statistical analysis section of protocols
·Full description of both temporary and closing analysis strategies

Consultation/Planning:

·Consultation on statistical or epidemiological problems
·Development of custom statistical analysis
·Forecasting and model building
·Preparation for discussions with regulatory agencies

Report Preparation and Submission:

·Preparation of integrated clinical/statistical reports
·Table and graphic design
·Planning, programming and execution of statistical analysis
·Summary of statistical methodologies used and preparation of statistical reports
·Submission of data in electronic format (SAS Export files) for eANDA or eNDA