Associate Director, Statistical Programming

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POST DATE 9/16/2016
END DATE 10/8/2016

Jazz Pharmaceuticals, Inc. Palo Alto, CA

Company
Jazz Pharmaceuticals, Inc.
Job Classification
Full Time
Company Ref #
360942
AJE Ref #
576197391
Location
Palo Alto, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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p The Associate Director, Statistical Programming will function as a programming lead on Jazz Pharmaceuticals clinical development projects.  This position will work collaboratively with biostatisticians, clinicians, data managers in the planning, conduct, and analysis of clinical studies in all phases. /p p strong Essential Functions /strong /p ul li type="disc" Lead Statistical Programmer on multiple complex projects or products in the Statistical Programming function, including NDA/BLA and other submissions to regulatory agencies /li li type="disc" Lead, manage, coach, develop, and support Statistical Programmers within the Biostatistics Department  /li li type="disc" Author or provide input to key study-related documents produced by other functions (e.g. Statistical Programming Plan, SAP, CRFs, Data Management Plan, etc.) /li li type="disc" Ensure the quality of Statistical Programming deliverables, including oversight of CRO biostatistics deliverables /li li type="disc" Participate and/or lead in the development and implementation of SAS programming standards, SOPs and work instructions, including program validation and documentation /li li type="disc" Ensure that the filing of study documentation is maintained to the standard required according to processes and is acceptable for audit /li li type="disc" Participate in vendor qualification/selection and monitor vendor performance /li li type="disc" Perform/assess time and resource estimates for project planning, managing timelines for studies/projects /li /ul