Provide sound statistical and operational input, including study and program design, writing of the protocol sections, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications; Partner with cross functional teams to provide strategic biostatistics input to support entire drug development process; ensure statistical integrity of all key deliverables; Provide statistically sound scientific methodology for study design and data analysis input to meet project objectives in accordance to regulatory guidance and industry standards; Collaborate with the programming and data management functions to ensure appropriate data collection and reporting; Provide leadership in evaluating alternative or innovative methods of study design and analysis; Assist in efforts to identify, develop and implement departmental standards, applications, processes and training; Oversees statistical and programming deliverables by CROs
Requirements:
PhD in Biostatistics or a related field with a minimum of 5 years of relevant experience in pharmaceutical or biotechnology drug development; Understanding and experience with various aspects of a clinical development life-cycle, leading up to regulatory submission and post-approval activities; Experience interacting with and overseeing biometrics services of CRO vendors; Proficiency in the use of statistical software including SAS and R at minimum; familiarity with East and Sportfire
Text:
Manager/Sr. Manager, Biostatistics Provide sound statistical and operational input, including study and program design, writing of the protocol sections, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications; Partner with cross functional teams to provide strategic biostatistics input to support entire drug development process; ensure statistical integrity of all key deliverables; Provide statistically sound scientific methodology for study design and data analysis input to meet project objectives in accordance to regulatory guidance and industry standards; Collaborate with the programming and data management functions to ensure appropriate data collection and reporting; Provide leadership in evaluating alternative or innovative methods of study design and analysis; Assist in efforts to identify, develop and implement departmental standards, applications, processes and training; Oversees statistical and programming deliverables by CROs PhD in Biostatistics or a related field with a minimum of 5 years of relevant experience in pharmaceutical or biotechnology drug development; Understanding and experience with various aspects of a clinical development life-cycle, leading up to regulatory submission and post-approval activities; Experience interacting with and overseeing biometrics services of CRO vendors; Proficiency in the use of statistical software including SAS and R at minimum; familiarity with East and Sportfire
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