EPM Scientific - Phaidon International
AD/Director Biostatistics
EPM Scientific - Phaidon International, Boston, Massachusetts, us, 02298
Associate Director/Director BiostatisticsBiostatistics | FDA Experience | CNS/NeurologyBoston, MA$180,000 - $230,000 +complete benefits packageA growing biotech company in the Greater Boston area is looking to hire an AD/Director Biostatistics candidate that would be responsible for all biostatistics and data analysis functions in support of clinical development programs. This candidate will play a key role in designing new clinical programs and protocols as well as working to lead regulatory submission and global health outcome efforts.
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The AD/Director Biostatistics will have responsibilities that include:Overseeing all of biostatistics and data analysis teamsServing as the leader for FDA/EMA meetings and Advisory committee meetingsAct as an active member of the protocol development team by providing statistical insight and guidanceContributing to vendor section and managementProviding operational statistical expertise for early to late phase clinical trial programsWriting and reviewing SAP as well as statistical protocols and SOPsThe ideal candidate will have the following skill set:10+ years in biostatistics in life sciences preferred.Experience with managing complex statistical data and with analytic statistical softwareExperiencing with modelling and bootstrapping methodsExperience with FDA regulatory submissionsFamiliarity with CDISC relating to FDA/EMA guidelines5+ years of experience in managing biostatistics teamsCNS/neurology experience preferred but not requiredExcellent verbal and written skillsMasters or Ph.D. in Biostatistics or related field
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Scroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect.
The AD/Director Biostatistics will have responsibilities that include:Overseeing all of biostatistics and data analysis teamsServing as the leader for FDA/EMA meetings and Advisory committee meetingsAct as an active member of the protocol development team by providing statistical insight and guidanceContributing to vendor section and managementProviding operational statistical expertise for early to late phase clinical trial programsWriting and reviewing SAP as well as statistical protocols and SOPsThe ideal candidate will have the following skill set:10+ years in biostatistics in life sciences preferred.Experience with managing complex statistical data and with analytic statistical softwareExperiencing with modelling and bootstrapping methodsExperience with FDA regulatory submissionsFamiliarity with CDISC relating to FDA/EMA guidelines5+ years of experience in managing biostatistics teamsCNS/neurology experience preferred but not requiredExcellent verbal and written skillsMasters or Ph.D. in Biostatistics or related field
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