
Statistical Analyst (Safety)
Leads the statistical programming activities of safety data integration and analysis for projects with lower complexity in creating integrated safety data sets to support safety monitoring, signal detection, clinical safety analytics and regulatory submissions. Leads the statistical programming activities for IB/DSUR/PSUR/ASR/RMP. Develop SAS programs for the creation of ADaM data sets following CDISC standards. Develops and oversees the development of SAS programs, Product safety data integration plan, metadata and ADaM data sets following CDISC standards. Develop SAS programs for the creation of Tables, Listings and Figures. Validation of ADaM data sets, Tables, Listings and Figures. Create specifications for the structure of ADaM data sets for individual studies and integrated data. Create documentation for regulatory filings including reviewers guides and data definition documents.
6+ years of relevant experience.
Indepth understanding of SAS programming concepts and techniques related to drug development.
Fundamental understanding of the drug development process, including experience with regulatory filings.
Time Management Skills
Statistical analysis techniques
SAS Macros
Validation of ADaM data sets
Clinical safety analytics
Safety data integration and analysis
Driven and self-motivated
Communication Skills
Multitasking Skills
Adaptability
Problem-solving and resourcefulness
Detail Oriented and Organized
According to JobzMall, the average salary range for a Statistical Analyst (Safety) in 1 N Waukegan Rd, Lake Bluff, IL 60044, USA is $68,000 to $90,000 per year.
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AbbVie is an American publicly traded biopharmaceutical company founded in 2013. It originated as a spin-off of Abbott Laboratories.

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