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 2 months ago

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Statistical Programmer 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) in accordance with FDA/CDISC or sponsor guidelines. Your role will involve developing SDTM specifications and generating SDTM datasets using SAS, as well as creating ADaM specifications and generating ADaM datasets based on the Statistical Analysis Plan. Additionally, you will be tasked with developing Tables, Listings, Graphs, and Patient Profiles to support Clinical Study Reports, Posters, and Manuscripts. Your duties will also include developing ADaM data, Tables, Listings, and Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE), as well as creating electronic submission packages for FDA...

Posted 2 months ago

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Senior Biostatistician and Statistical Programmer Gratitude India

3.0 - 8.0 years

20 - 25 Lacs

Hyderabad, Bengaluru, Mumbai (All Areas)

Work from Office

Lead clinical trial statistics: develop protocols, design studies, create TLGs, review ADaM specs. Manage statistical deliverables, mentor team, collaborate cross-functionally. Support CTR prep, regulatory submissions, QC validation. Required Candidate profile Postgrad/PhD Statistics. 3+ yrs clinical trial biostatistics experience. Expertise in protocol design & statistical programming (SAS/R). Regulatory submission knowledge. Team leadership abilities.

Posted 3 months ago

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