Abbreviated job description - if interested please contact Gerard Group for full details. taylor at gerardgroupinc dot comLead the statistical strategy across a development programRepresent Client in interactions with regulatory authorities as they pertain to statistical issuesParticipate in study design and protocol developmentEnsure that study designs are consistent with study objectives and are optimal within study constraintsCalculate sample sizes and/or perform power calculations for proposed studies as well as for alternativedesigns to evaluate the costs and timelines of various scenarios QUALIFICATIONSMaster’s degree or Ph.D. in statistics, biostatistics, mathematics, or related field8+ years of prior experience in a drug-development environmentAbility to manage multiple and diverse issuesNDA/ BLA Experience
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