Job Description
Summary of Position:
The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing.
Duties and Responsibilities:
• Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.
• Review CRF, database design, and edit check specs
• Review study quality surveillance plan and monitor study conduct
• Prepare and/or review SAP, TFL shells and specifications for variable derivation
• Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variable...
The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing.
Duties and Responsibilities:
• Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.
• Review CRF, database design, and edit check specs
• Review study quality surveillance plan and monitor study conduct
• Prepare and/or review SAP, TFL shells and specifications for variable derivation
• Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variable...
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