Provides statistical leadership in design, analysis, and interpretation on projects assigned; Independently represents biostistics function in ADTs (Asian development teams); Provide statistical inputs to feasibility assessments, development and submission plans, and defense strategy of regulatory submissions to China regulatory authories; In collaboration with GPT statisticians, represents Statistics function in interactions with regulatory authorities on regulatory submission and regulatory defense in China
Requirements:
Demonstrated solid knowledge of common statistical theory and methodologies and their practical applications in clinical development, peferreably by a graduate degree in Statistics or an related field plus professional experience in pharmaceutical industry; Knowledge of the pharmaceutical industry including understanding of drug development process and industry standards applicable to the design, analysis, and reporting of clinical trials; Knowledge of NMPA and ICH regulations related to clinical statistics
Text:
Senior Manager, Biostatistics Provides statistical leadership in design, analysis, and interpretation on projects assigned; Independently represents biostistics function in ADTs (Asian development teams); Provide statistical inputs to feasibility assessments, development and submission plans, and defense strategy of regulatory submissions to China regulatory authories; In collaboration with GPT statisticians, represents Statistics function in interactions with regulatory authorities on regulatory submission and regulatory defense in China Demonstrated solid knowledge of common statistical theory and methodologies and their practical applications in clinical development, peferreably by a graduate degree in Statistics or an related field plus professional experience in pharmaceutical industry; Knowledge of the pharmaceutical industry including understanding of drug development process and industry standards applicable to the design, analysis, and reporting of clinical trials; Knowledge of NMPA and ICH regulations related to clinical statistics
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