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.
Qualifications
QUALIFICATIONS NEEDED:
• Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/Statistics with at least 3 years of experience in the pharmaceutical, CRO or biotech industry.
• Oncology experience is required (min 1 year).
• Good technical writing skills.
• Good communication skills (verbal and written).
• Strong teamwork ability/commitment and individual initiative.
• Strong organizational skills with ability to effectively manage multiple projects.
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