Senior Statistical Programmer I & II Desirous Global Consulting

8.0 - 13.0 years

0 Lacs

chennai, tamil nadu

On-site

Role Overview: You will be responsible for annotating Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. You will develop SDTM specifications and generate SDTM datasets using SAS. Additionally, you will develop ADaM specifications and generate ADaM datasets using SAS based on the Statistical Analysis Plan. Your role will involve developing Tables, Listings, Graphs, and Patient Profile in support of the Clinical Study Report, Posters, and Manuscripts. Furthermore, you will create electronic submission packages to FDA, such as define.xml or define.pdf, following FDA guidelines with minimum supervision. You will also analyze information and provide innovative solutions to pr...

Posted 2 weeks ago

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Senior Statistical Programmer I & II Desirous Global Consulting

8.0 - 13.0 years

0 Lacs

chennai, tamil nadu

On-site

You will be responsible for annotating Case Report Form (acrf.pdf) according to FDA/CDISC or sponsor guidelines. Your role will involve developing SDTM specifications and generating SDTM datasets using SAS. Additionally, you will develop ADaM specifications and create ADaM datasets using SAS based on the Statistical Analysis Plan. Furthermore, you will be tasked with developing Tables, Listings, Graphs, and Patient Profile to support the Clinical Study Report, Posters, and Manuscripts. You will also work on developing ADaM data, Tables, Listings, and Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). You will create electronic submission packages for FDA...

Posted 3 months ago

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