The Manager, Biostatistics will be a key member of the Biometrics function with accountability for biostatistical activities in Bicycle clinical studies. In addition to the oversight on Biostatistics counterpart from vendors, he/she will provide key biostatistical input and quantitative deep thinking to support a wide variety of projects in clinical development. The Senior manager of Biostatistics will closely collaborate with partner functions such as Medical, Clinical Science, Clinical Operation, Data Management, Statistical Programming, etc. This position reports to Senior Director, Biostatistics.The ideal candidate has a demonstrated good understanding of statistical analysis and clinical trial design, proficient programming skills using R and SAS, as well as excellent communication skills.Serves as study biostatistician in the cross-functional teams for the clinical trial planning, execution, and reportingProvide oversight of outsourced biostatistical activities under supervision, including protocol development, case report form (CRF) development, statistical analysis plan (SAP) and table, figure, and listing (TFL) shells, SDTM and ADaM dataset specifications review development for interim and final analysesCoordinate with other functional areas, and management of timelines relating to key milestones and ensuring outsourced work is performed with high quality; provide statistical QC as neededProvide inputs on study related reports and ensure the accuracy, including clinical study reports (CSRs) and safety reporting etc.Provide statistical programming support (SAS and R) to internal ad-hoc requests/analysesProvide support as needed (technical, clinical) to ensure efficient action, collaboration and resolution of biostatistical issues 
