Sanofi Group Sr. Manager Biostatistics (Biostatistician) in Bridgewater, New Jersey
Sr. Manager Biostatistics (Biostatistician)
Sanofi, a global healthcare leader, discovers, develops anddistributes therapeutic solutions focused on patients’ needs. Sanofi has corestrengths in diabetes solutions, human vaccines, innovative drugs, consumerhealthcare, emerging markets, animal health and Genzyme.
At Sanofi US, we are committed to the growth of our people,connected in purpose by career, life and health.
Headquartered in Bridgewater, NJ, Sanofi US is part of aleading global healthcare company dedicated to discovering, developing anddistributing therapeutic solutions focused on patients’ needs.
Sanofi has core strengths in diabetes solutions, human vaccines,innovative drugs, consumer healthcare, emerging markets, animal health andGenzyme.
Sanofi US employs approximately 17,000 people across thecountry all dedicated to protecting health, enhancing life and responding tothe hopes and potential healthcare needs of seven billion people around theworld.
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Sr. Manager, Biostatistics
As a member of the Biostatistics and Programming Department,the individual supports primarily early phase clinical trials, including PhaseI and Phase IIa proof-of-concept trials, across therapeutic or disease areas.He/she collaborates closely with study team members including clinicalpharmacologists, study clinicians, trial managers, data managers, andpharmacokineticists on day-to-day basis. The statistician’s responsibilitiesinclude developing statistical sections of study protocols including samplesize determination, reviewing CRFs, participating in the development andimplementation of Data Review and Surveillance Plans, formulating anddeveloping sound statistical analysis strategies and developing the statisticalanalysis plans, drafting TLG shells, validating analysis programs according tothe SAP, performing statistical analyses, and preparing statistical method andresult sections for clinical study reports, and working with medical writersand other study team members to move Clinical Study Report (CSR) through thereview, finalization and approval process. Furthermore, the individualparticipates in the development of early phase project development strategiesand plans, contributes to the development or improvement of BiostatisticsDepartmental standards and processes. A strong candidate will possess theability to carry out statistical research and is interested in applyinginnovative thinking and advanced approaches to the designs and data analyses ofclinical trials.
A PhD degree in statistics or biostatistics with 2-4 years experience in pharmaceutical industry is required.
Knowledge in Bayesian analysis, adaptive designs, and/or biomarker analysis is desired.
The candidateshould have in depth understanding of statistical concepts and techniques,ability to perform statistical research and simulation.
The candidate must haveexcellent communication and interpersonal skills, be highly self-motivated, andhave ability to successfully conduct multi-tasks, work independently withminimal supervision, pay attention to details and work well in a teamenvironment.
Job: Clinical Development
Primary Location: United States-New Jersey-Bridgewater
Job Posting: Oct 12, 2016, 8:21:53 AM
Job Type: Regular
Employee Status: Regular