Serve as the biostatistician in clinical development teams responsible for all clinical study biostatistics deliverables with high quality and on time; Responsible to bring innovative statistical thinking and operational excellence to help drive applications of state-of-art statistical methods that increase the probability of successes for clinical development programs; Develop statistical sections of protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses; Plan, manage, and track biostatistics activities, timelines, and resources and assure operational excellence; Contribute to SOPs and/or Work Instructions related to biostatistics practices
Requirements:
PhD in statistics (or equivalent degree) with 4+ years or master with 7+ years of relevant working experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations; Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems; Working knowledge of relevant ICH guidelines, US, EU and other regions’ regulations; Experience working on oncology, vaccine/infectious disease and rare disease clinical studies and regulatory interactions are preferred; Experience working with CROs, vendors, and relationship management
Text:
Sr. Manager, Biostatistics Serve as the biostatistician in clinical development teams responsible for all clinical study biostatistics deliverables with high quality and on time; Responsible to bring innovative statistical thinking and operational excellence to help drive applications of state-of-art statistical methods that increase the probability of successes for clinical development programs; Develop statistical sections of protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses; Plan, manage, and track biostatistics activities, timelines, and resources and assure operational excellence; Contribute to SOPs and/or Work Instructions related to biostatistics practices PhD in statistics (or equivalent degree) with 4+ years or master with 7+ years of relevant working experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations; Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems; Working knowledge of relevant ICH guidelines, US, EU and other regions’ regulations; Experience working on oncology, vaccine/infectious disease and rare disease clinical studies and regulatory interactions are preferred; Experience working with CROs, vendors, and relationship management
Please click here, if the job didn't load correctly.
Please wait. You are being redirected to the job in 3 seconds.
