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Sr Biostatistician

Montgomery, NJ

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Johnson& Johnson Consumer Inc is hiring a Senior Biostatistician, as part of ournQuantitative Sciences group. Thisnposition will be located in our Skillman, NJ site and will collaborate with ournUS and Global Consumer and OTC clinical project teams. Johnsonn& Johnson Consumer Inc. (JJCI) touches more than a billion peopleu2019s livesneach day through our health care products and services, our corporate giving,nand the volunteer efforts of our employees. JJCI develops and markets belovednbrands that address the needs of consumers and health care professionalsnworldwide. Our portfolio ranges across several distinct business units: OTCnproducts such as Pain, Allergy, and Cough/Cold; Baby Care, Oral Care,nCompromised Skin Care, Beauty, and Feminine Care. Thenbiostatistician in this role provides study-level statistical expertise innsupport of the design, analysis, and interpretation of clinical trials throughncollaboration with other team personnel including data management, programming,nclinical research, and clinical operations. This support includes statistical aspects of study design, protocolnreview, and preparation of statistical sections; preparation of the statisticalnanalysis plan; oversight of tables/listings/figures development; interpretationnof results to internal clinical and management personnel; and support of thenpreparation of publications and regulatory deliverables. Innproviding clinical trial support, this person will participate in management ofnexternal resources to ensure quality, timely, and cost-effective statisticalndeliverables. Responsibilities: Represent the biostatistics function in supporting the design, analysis, and interpretation of clinical trials through collaboration with other functions including Clinical Research, Clinical Operations, Data Management, and ProgrammingProvide statistical input to clinical plans in support of product development, claims, and submissionsProvide statistical support to the development and review of study protocols, statistical analysis plans, clinical study reports, regulatory submissions, and other related deliverablesParticipate in oversight of biostatistics activities of external vendors to ensure quality and timeliness of deliverables Assist clinical and other personnel in the creation of publications and manuscriptsSupport the development and implementation of process efficiencies and continuous improvements to decrease cycle time and reduce cost while maintaining/improving quality.Assist in support for interactions with and responses to regulatory agencies.Ensure compliance with all statistical analysis and reporting proceduresnQualificationsGraduate degree in Statistics or a related quantitative field with sufficient concentration in statistics required PhD degree or equivalent; or MS degree or equivalent with 3 years pharmaceutical experience required Experience with statistical computing software including SAS requiredExcellent oral and written communication skills, and strong interpersonal skillsExcellent problem-solving skillsn

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