Manager, Biostatistics

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POST DATE 8/27/2016
END DATE 11/6/2016

Jazz Pharmaceuticals, Inc. Palo Alto, CA

Company
Jazz Pharmaceuticals, Inc.
Job Classification
Full Time
Company Ref #
360355
AJE Ref #
575993146
Location
Palo Alto, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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p The Manager, Biostatistics will be acting as a project-level and study-level statistician.  This role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data management, clinical operations, biostatistics, and clinical data analysis and will oversee the work of statistics and programming external vendors. /p p strong Essential Functions /strong /p ul li type="disc" Provide timely and scientifically sound statistical expertise to clinical development projects. /li li type="disc" Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies. /li li type="disc" Collaborate with members of project teams to establish project timelines and to develop and implement protocols /li li type="disc" Work closely with data management, clinical operations, clinical data analysis, and other biostatisticians to develop and validate study-specific data capture systems /li li type="disc" Develop statistical analysis plans, coordinate and perform data analysis and validation as necessary, and provide data interpretation. /li li type="disc" Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results. Provide guidelines and standards to CROs to ensure quality of deliverables. Participate in CRO selection process. /li li type="disc" Attend regulatory meetings to support and defend clinical programs. /li li type="disc" Collaborate with clinical scientists, thought leaders, and medical writers, both internally and externally, in the publication of study data. /li li type="disc" Stay current with new developments in statistics, drug development and regulatory guidance through literature review, conference attendance, etc. /li /ul