Responsible for all aspects of statistical planning, methodology, and analysis or oversight of such tasks per-formed by an external vendor: Review CRF, database and dataset structure, Data Management Plan, Data Quality Plan, Data Review Guidelines and edit specifications; Provide input into clinical study protocol and create/review/approve statistical analysis plan (SAP).
Interface with in-house staff: Participate on Project Teams
Review monitoring guidelines.
Work with internal staff or vendors to assure that all programming and statistical analyses are properly con-ducted and validated to allow for proper analysis and interpretation required for inclusion into reports and regulatory submissions.
Identification, creation and maintenance of department procedures: Participate in departmental initiatives related to process building and improvement.
Work within R&D, as necessary, to implement global programming and statistical analysis procedures, processes and standards..