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Services
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Clinical development plan strategy
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Study design, endpoints selection, and analysis strategy
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Develop protocol statistic methodology section
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Review/write CSR statistical methods and results sections
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Represent client in interaction with FDA
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Study sample size and power assessment
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Review literature and historical data
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Design, review, and implement statistical analysis plan, including interim analysis plan
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Manage and mentor internal junior staff
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Evaluate and manage CROs for data management and statistics activities
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Pharmacokinetics analysis
w
Publication support
w
Data mining
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Experimental design and data analysis for CMC