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Abstract Details
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Activity Number:
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112
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 30, 2012 : 8:30 AM to 10:20 AM
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Sponsor:
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Section for Statistical Programmers and Analysts
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| Abstract - #306559 |
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Title:
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A Typical Work Day of a Biostatistician in a Medical Device Company
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Author(s):
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Frank Yi*+
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Companies:
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Johnson & Johnson
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Address:
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Clinical Affairs, Research & Development, Jacksonville, FL, 32256-0517, United States
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Keywords:
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CRO ;
SAP ;
510K ;
PMA
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Abstract:
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A Typical Work Day of a Biostatistician in a Medical Device Company 8:30 Protocol xyz review meeting 9:30 SAP for protocol abc discussion with CRO wxy 11:00 prepare randomization scheme for protocol xyy 13:30 sample size discussion for 510k/PMA study with project director 14:30 data spec discussion with CRO on study protocol xxxx 16:30 Discuss responses to the FDA queries with RA staff 15:00 telephone conference with FDA personnel Minimum skills and experience that we need to have to do our daily work Seek first to understand then to be understood Outsourcing and overseeing CRO and internal team chemistry management
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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