- Assist with protocol development, sample size calculation, protocol and case report form (CRF) review
- Advise data management staff on database design, and be responsible for critical data and data quality review
- Prepare randomization specifications; generate schedules; verify randomization components (specification and schedule)
- Responsible for development of Statistical Analysis Plans, to include statistical methodology, statistical programming procedures, definition of derived variables, data–handling rules and mockups
- SAS programming and related activities for the presentation and analysis of clinical trial data
- Provide support for special committees, e.g., DMCs including input/review of charters and maintenance of appropriate blinding
- Responsible for statistical input to statistical reports and Clinical Study Reports
- Understand the submission issues, having the ability to communicate with experts in CDE in an effective manner
- Support of Business Development, e.g. by attending and preparing bid defense meetings
- Interact with clients as key contact with regard to statistical and contractual issues
- Provide consulting services in statistical field, which includes but not limited to study design interpretation, problem-solving in implementation, data-examination guidance and research-result explanation