Collaborates with Clinical Development, Clinical Pharmacology, 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 and Data Presentation Plans; Collaborates with Data Management, Clinical Development, Clinical Pharmacology 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 and/or reviews ADS and ad hoc analysis specifications
Requirements:
PhD in Biostatistics, Statistics, or equivalent with at least 4 years pharmaceutical biostatistics experience or MS with at least 6 years of relevant experience; Excellent written and oral communication skills; Excellent presentation and interpersonal skills; Experience programming in SAS; Experience with simulations (design, implementation and interpretation); Understanding of ICH GCP as well as general knowledge of industry practices and standards; Familiarity with R programming language and other statistical software, including EAST
Text:
Senior Manager, Biostatistics Collaborates with Clinical Development, Clinical Pharmacology, 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 and Data Presentation Plans; Collaborates with Data Management, Clinical Development, Clinical Pharmacology 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 and/or reviews ADS and ad hoc analysis specifications PhD in Biostatistics, Statistics, or equivalent with at least 4 years pharmaceutical biostatistics experience or MS with at least 6 years of relevant experience; Excellent written and oral communication skills; Excellent presentation and interpersonal skills; Experience programming in SAS; Experience with simulations (design, implementation and interpretation); Understanding of ICH GCP as well as general knowledge of industry practices and standards; Familiarity with R programming language and other statistical software, including EAST
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