Statistical Consulting Services Sample Size/Power Calculations Experimental Design Consulting including Adaptive Designs Write Statistical Sections of Protocols Strategic Planning for Clinical Research Plans Consulting on Statistically Related Regulatory Issues Write Statistical Sections of Regulatory Submission Documents Write Interim Analysis Plans Service on Data Monitoring Committees and Data Safety Monitoring Boards Completion of FDA Pivotal IDE Description Forms Bayesian and Frequentist Data Analyses of Medical Device Trials Statistical Programming of TLGs for DMCs and DSMBs Stability Study Data Analysis and Reporting Sampling Plans for Validation Studies and Manufacturing Applications Development of Statistical Models for Diagnostic Devices Randomization Tasks