• Provide statistical expertise and collaborate with various functions on study design/planning, protocol development, statistical methodology/analysis • Responsible for the development of statistical analysis plan (SAP), TFL shells and other analysis specifications on assigned studies • Responsible for the development of randomization schema on assigned randomized studies • Perform data analysis and/or collaborate with statistical programming (inhouse or vendor) to ensure quality analysis conducted per the SAP and specifications • Responsible for the development of statistical reports summarizing the data analysis results • Ensure adequate interpretation of data/analysis results and consistency/accuracy of data presentation for study reports and publications • Collaborate with various functions to ensure robust CRF/EDC development, and quality data collection for the assigned clinical trials • Provide quality review of outsourced statistical deliverables (including in-house double programming to QC as needed) and coordinate the in-house review comments • Stay abreast of industry development in biostatistics/statistical programming fields and apply to appropriate systems and processes • Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time