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Form of workDescription
We're looking for a Biostatistician Manager, working in Pharmaceuticals and Medical Products industry in 155 Tice Boulevard, Woodcliff Lake, New Jersey, 07677, United States.- Participate in study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc.
- Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others.
- Work with 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 programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables.
