- Strategic input to the design and analysis of clinical protocols and clinical development plans, including operational and outsourcing considerations
- Review and evaluation of clinical protocols and clinical development plans
- Review and/or preparation of statistical sections for protocols
- Review and/or preparation of statistical analysis plans for submission to regulatory agencies
- Review and evaluation of statistical analyses, clinical study reports, integrated summaries of efficacy, and integrated summaries of safety
- Provide statistical expertise as a member of data safety monitoring committees
- Provide due diligence review of clinical trial information for in-licensing and acquisition decisions
- Provide a statistical and operational perspective to development strategies as a member of scientific advisory boards
- Strategic input, review and evaluation of regulatory submissions from an experienced statistical perspective
- Provide statistical/operational advice for regulatory strategies
- Serve as the company's statistical representative to regulatory agencies if that expertise does not exist internally
- Plan strategy for meetings with FDA staff and presentations to FDA advisory committees, including participation in mock FDA advisory committee meetings
- Provide technical expertise and expert testimony related to litigation
- Assist the company in planning and negotiating with contract research organizations
- Provide an interface between the company and contract research organizations
- Conduct in-house courses in various statistical topics such as experimental design and sample size estimation
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