Clinical Trials:
- Clinical trial design, sample size calculation, analysis and analysis strategy, in Phases I, II, III, IV
- Protocol review and preparation of statistical methods sections
- CRO selection and management of CRO deliverables and timelines
- Preparing randomizations, including specifications and acceptance testing for IVRS
- Case report form review and recommendations, both EDC and paper
- Designing and supervising data collection, management and databases
- Statistical analysis plans, including tables, listings and graph shells
- Negotiating statistical issues with the FDA statisticians
- 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
- Planned and ad hoc analysis of clinical trial data
Outcomes Research and Health Economics
- 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
Professional Organizations