Chris Barker — Statistics

Clinical Trials:

Clinical trial design, and statistical analysis for Phases I, II, III, IV
Medical Device trial design and statistical analysis
Diagnostics, including Genomics trial design, statistical analysis and validation, including use of CLSI guidelines
Protocol review and preparation of statistical methods and analysis plans
Sample size calculation and simulation
Development of clinical trial endpoints acceptable to regulatory agencies
CRO selection and management of CRO deliverables and timelines
Preparing randomizations, including specifications and acceptance testing for IVRS
Case report form review, both EDC and paper
Designing and supervising data collection, management and clinical trial database design
Represent sponsor at meetings with FDA and other regulatory agencies
Management of SAS statistical programming and preparation of outputs acceptable to the regulatory authorities
Independent verification of statistical results
Interpretation of statistical findings and preparation of final clinical study reports
Preparation of statistical analyses for manuscripts

Preparation of statistical analyses supporting Health Economics Value Messages , Cost Effectiveness, Cost Utility and Cost Consequences Models
Statistical Analysis of Patient Reported Outcome Data
Patient Reported Outcome instrument selection
Statistical analysis of Resource Use Data
Statistical analysis and estimation of parameters required in Cost Effectiveness models
Statistical analysis of Registry and Insurance Claims Databases

Adjunct Associate Professor of Biostatistics
University of Illinois, Chicago –School of Public Health