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, such as define.xml or define.pdf, following FDA guidelines with minimal supervision. As part of your responsibilities, you will analyze information and devise innovative solutions to programming and data analysis challenges. Effective communication with statisticians for statistical input and analysis interpretation is essential in this role. You will need to adhere to regulatory agency requirements on a daily basis. As a programming team lead, you will also contribute to departmental initiatives and provide guidance, mentoring, and training to team members while assisting in issue resolution within cross-functional teams. To be considered for this position, you should possess a Master's or Bachelor's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology, or related scientific disciplines. Additionally, you should have 8-13 years of experience in Statistical Programming within the Clinical domain.,

Posted 2 days 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, such as define.xml or define.pdf, following FDA guidelines with minimal supervision. You will be expected to analyze information, provide innovative solutions to programming and data analysis challenges, and communicate effectively with statisticians for statistical input and analysis interpretation. As part of your role, you will need to adhere to regulatory agency requirements on a daily basis, act as a programming team lead, and contribute to department initiatives. Furthermore, you will be responsible for providing guidance, mentoring, and training to team members, as well as assisting in issue resolution for cross-functional teams. You will also review draft and final production deliverables for projects to ensure quality and consistency. To be successful in this position, you should possess a Master's or Bachelor's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology, or related scientific disciplines. Additionally, you should have 8-13 years of experience in Statistical Programming within the Clinical domain.,

Posted 1 week 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 1 month ago

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