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Princeton, NJ

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Job #684156342
**MEMBERS ONLY**SIGN UP NOW***. is located in Princeton NJ, which is a leader in pharmaceutical recruitment and staffing. Our goal is to provide effective solutions for fulfilling your career potential. The mission of our company is to connect high talent and motivated candidates to technical positions from our partner companies To know more about **MEMBERS ONLY**SIGN UP NOW***., please visit our website ~~~. We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, and we currently have a job opening that may interest you. Below is a summary of the position. If you are interested in the opportunity listed below, please forward your updated resume along with current contact information, or perhaps you can recommend someone who would be interested in this position. Job Title: Clinical Statisticatian Location: New Jersey Type: Fulltime Essential Functions:Responsible for study designs and data analyses from Phase I studies, including pharmacokinetic and bioequivalence/bioavailability studies, pharmacodynamics, QT/QTc studies, and the earliest studies in humans Responsible for statistical aspects of the analysis of pharmacokinetic data from Phase II and Phase III studies and exposure-response analyses Provides study design input and consultation for clinical endpoint assessments and sample size planning for clinical pharmacology studies Prepares, or oversees the preparation of statistical sections of clinical protocols in collaboration with Clinical Pharmacology personnel, and with Clinical Research, as deemed necessary. Writes, or oversees the writing of, statistical analysis plans Works with Data Management and Clinical Research personnel to provide statistical input for CRF design Conducts, or oversees the conduct of, analyses to support clinical study reports, abstracts, manuscripts and other documents to support the marketing of Teva Global R&D products Conduct, or oversight of the conduct of analyses and document preparation to support global regulatory submissions, including briefing packages, integrated analyses and regulatory responses. Leads efforts to select CROs for outsourcing of statistical activities when required Collaborates with outsourcing partners and oversees conduct of statistical aspects of outsourced studies, as appropriate Support the development (and adaptation) of the strategy around the Clinical Pharmacology Operating Model Proactively assess and identify processes that require improvement Help develop and maintain departmental SOPs and ensure their compliance in daily work Requirements:Ph.D. in Statistics/Biostatistics (or related field) with a minimum of 3 years of related experience or MS/MA with a minimum of 5 years of experience is required; Good presentation and written communications skills. Ability to communicate with non-statisticians to interpret statistical findings Experience working in an outsourcing model (fully or functional outsourcing) Good organizational and problem-solving skills. Demonstrated project and technical leadership qualities, and creative and strategic thinking preferred. Ability to program using SAS Knowledge of CDISC SDTM and ADaM Knowledge of relevant FDA and CHMP guidelines Experience with regulatory interactions in the US Experience with regulatory interactions outside the US
Updated 06/12/2018

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