Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies; Provide statistical oversight to studies and assure adequate quality and consistency with project requirements; Responsible for assuring that data for statistical analyses are complete, accurate and consistent; Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions; Responsible for validity of analysis and explore alternative analysis strategies as needed
Requirements:
MS or PhD in Statistics, Biostatistics or related field. PhD with 3-5 years of experience or MS with 6-8 years of experience; Strong oral and written communications skills, with ability to effectively communicate internally and with clients; Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations; Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA
Text:
Principal Biostatistician Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies; Provide statistical oversight to studies and assure adequate quality and consistency with project requirements; Responsible for assuring that data for statistical analyses are complete, accurate and consistent; Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions; Responsible for validity of analysis and explore alternative analysis strategies as needed MS or PhD in Statistics, Biostatistics or related field. PhD with 3-5 years of experience or MS with 6-8 years of experience; Strong oral and written communications skills, with ability to effectively communicate internally and with clients; Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations; Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA
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