Create specifications for the structure of ADaM data sets for individual studies.
Develop SAS programs for creation & validation of ADaM data sets following CDISC standards & of Tables Listings & Figures.
Ensure accuracy of SAS programs by reviewing code log & output files.
Review output to ensure consistency with output for other activities (CSR ISS ISE).
Create documentation for regulatory filings including reviewers guides & data definition documents.
Participate in development of SAS Macros.
Requirements:
Must possess a BS or foreign academic equivalent in Statistics Biostatistics Computer Science or a related field.
Must have 6 years of experience in pharmaceutical industry.
developing reviewing & executing code using SAS Enterprise Guide &/or SAS Studio.
performing programming tasks including data processing & manipulation using SAS BASE data analysis using SAS STAT & data reporting using SAS ODS.
using SAS macro variables & macro functions including debugging the macro.
developing & validating programming code for derivation of key variables in Trial Design SDTM domains.
developing & validating ADaM datasets in compliance with CDISC standards & developing Tables Listings & Figures.
developing & validating programming code using SAS procedures to implement statistical methodologies for analysis of categorical & continuous variables including linear regression categorical data analysis survival analysis & significance testing.
creating or reviewing documentation for regulatory filings including reviewers guides & data definition documents.
complying with FDA EMA & other regulatory agencies/ICH guidelines & relevant regulatory requirements.
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