Represents biostatistics at cross-functional team meetings to drive clinical development of drug candidate and provides input on clinical development plans; Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials; Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts; Contributes to or prepares statistical analysis plans; Collaborates with Data Management, Clinical Development and Clinical Operations on design of eCRFs; Provides statistical guidance on conduct of ongoing trials; Collaborates with Statistical Programmers on summary and analysis of trial data; Writes ADS and ad hoc analysis specifications
Requirements:
Ph.D. in Biostatistics or Statistics or Equivalent with at least 7 years pharmaceutical biostatistics experience; or MS with at least 10 years relevant experience; Excellent written and oral communication and presentation skills; Experience programming in SAS
Text:
Associate Director, Biostatistics Represents biostatistics at cross-functional team meetings to drive clinical development of drug candidate and provides input on clinical development plans; Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials; Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts; Contributes to or prepares statistical analysis plans; Collaborates with Data Management, Clinical Development and Clinical Operations on design of eCRFs; Provides statistical guidance on conduct of ongoing trials; Collaborates with Statistical Programmers on summary and analysis of trial data; Writes ADS and ad hoc analysis specifications Ph.D. in Biostatistics or Statistics or Equivalent with at least 7 years pharmaceutical biostatistics experience; or MS with at least 10 years relevant experience; Excellent written and oral communication and presentation skills; Experience programming in SAS
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