Lead complex clinical trials or indication corresponding to one or several compounds in development; Represents Biostatistics as a member of cross functional teams, accountable for statistical aspects of statistical design, study setup, execution, analysis and reporting of clinicals; Manage the timelines and oversee the quality of statistical analyses by CRO or internal teams; Undertake new and highly complex issues requiring advanced analytical thought with minimal supervision; Support global submission deliverables as needed including responses to health authority queries, advisory committee meeting preparation, etc; Provide statistical support for the Biometrics Department’s infrastructure needs
Requirements:
MS in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experience or a PhD in Statistics/Biostatistics with more than 6 years of’ relavant pharmaceutical experience; Knowledge of pharmaceutical environment and regulatory requirements; Comprehensive knowledge and understanding of advanced statistical concepts and techniques applicable to Clinical Research
Text:
Assoc Director, Biostatistics Lead complex clinical trials or indication corresponding to one or several compounds in development; Represents Biostatistics as a member of cross functional teams, accountable for statistical aspects of statistical design, study setup, execution, analysis and reporting of clinicals; Manage the timelines and oversee the quality of statistical analyses by CRO or internal teams; Undertake new and highly complex issues requiring advanced analytical thought with minimal supervision; Support global submission deliverables as needed including responses to health authority queries, advisory committee meeting preparation, etc; Provide statistical support for the Biometrics Department’s infrastructure needs MS in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experience or a PhD in Statistics/Biostatistics with more than 6 years of’ relavant pharmaceutical experience; Knowledge of pharmaceutical environment and regulatory requirements; Comprehensive knowledge and understanding of advanced statistical concepts and techniques applicable to Clinical Research
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