Dallas, Texas, United States
Acts as the lead statistician for multiple projects with any level of complexity. Acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects. Helps manage clinical trials efficiently by providing accurate and consistent information to both sponsors and Company business/functional units.
• Serves as a lead Biostatistician (i.e., primarily contact sponsors, management of timelines) • Develops Statistical Analysis Plans (SAPs) based on the protocol, including development of well-presented mock-up displays for tables, listings and figures. • Creates and reviews programming specifications for analysis datasets/tables/listings/figures. • Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. • Participates in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting statistician.
• Perform validation of tables, listings and figures (TLFs), per the Statistical Analysis Plan, CRF and specifications • Generate well-formatted TLFs for submission to the sponsor • Program and quality control of CDISC SDTM and ADaM dataset. • Develop TLF specifications • Work on multiple studies moderate to complicated and manage deliverables against stringent timelines