About The Position
Key Responsibilities: Provide technical leadership in SAS programs and applications designed to analyze and report complex clinical trial data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format, with minimal instruction or input from supervisor Provide technical leadership to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission Ensure compliance with company SOP'S and FDA/ICH/GCP regulations Perform quality control checks of advanced SAS code for datasets and output produced by other statistical programmers Review, maintain study documents per standard process Program, test, and document global utility programs and tools in accordance with standards and validation procedures Conduct briefings and participate in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMA, et cetera) for projects Perform lead duties when called upon Perform other duties as assigned
Responsibilities
- Provide technical leadership in SAS programs and applications designed to analyze and report complex clinical trial data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format, with minimal instruction or input from supervisor
- Provide technical leadership to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission
- Ensure compliance with company SOP'S and FDA/ICH/GCP regulations
- Perform quality control checks of advanced SAS code for datasets and output produced by other statistical programmers
- Review, maintain study documents per standard process
- Program, test, and document global utility programs and tools in accordance with standards and validation procedures
- Conduct briefings and participate in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMA, et cetera) for projects
- Perform lead duties when called upon
- Perform other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
No Education Listed
Number of Employees
501-1,000 employees
