Senior Biostatistician Description:
• 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, and 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.
• Act as lead Statistician on complex trials and across multiple studies.
• Act as a lead representative of the of the biostatistics department on project teams.