Act as lead and main point of contact related to Statistics for designated compound/indication; Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies; Engage with regulatory authorities on compound/indication level discussions; Acts as a role model; Ensures consistency of statistical methods and data handling across trials; Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
Requirements:
Master's or PhD in a statistical field with 8+ (AD) and 12+ years (Director) of experience in relevant technical area; Experience in statistical analysis, modelling and simulation and adaptive trial designs; Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred; Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics; Experience with the relevant regulatory requirements for biostatistics processes and SOPs
Text:
(Associate) Director, Biostatistician Act as lead and main point of contact related to Statistics for designated compound/indication; Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies; Engage with regulatory authorities on compound/indication level discussions; Acts as a role model; Ensures consistency of statistical methods and data handling across trials; Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor Master's or PhD in a statistical field with 8+ (AD) and 12+ years (Director) of experience in relevant technical area; Experience in statistical analysis, modelling and simulation and adaptive trial designs; Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred; Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics; Experience with the relevant regulatory requirements for biostatistics processes and SOPs
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