·Work closely with clinicians, programmers, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review.
·Work with the clinical study team on study design, development and/or review of clinical study protocols.
·Develop and/or review statistical analysis plans, including Table/listing/figure shells, and final study report for clinical studies; perform post-hoc statistical analyses as needed.
·Work with the project statistician and clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality.
·Oversee CRO programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, ensure the quality of CRO deliverables.
May work with the Health Outcome team on the design/analysis/validation of projects. May work on submission teams as a statistician and/or a programmer.