Biostatistical Programming Manager
About this role
Biostatistical Programming Manager
Duties: Drive Case Report Form design and data collection strategy within the Clinical Study Team to influence it for purpose data collection decisions while ensuring successful analysis and submission; Review Study Data Tabulation Model (SDTM) datasets and related specification and submission documents for analysis and regulatory submissions; Provide Clinical Data Interchange Standards Consortium expertise and guidance to the Clinical Study Team including the Global Statistical Programming team and cross functional partners for implementation and mapping; Author and review Study Data Tabulation Model submission files; Review Study Data Tabulation Model data conformance checks output and study team dispositions on selected snapshots as determined by need and perform Study Data Tabulation Model audit for all pivotal snapshots; Support global standards…
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