Global Lead Statistical Programmer SUN PHARMA

7.0 - 9.0 years

0 Lacs

india

Remote

Grade: Manager Location: Hybrid at Gurugram/Mumbai. 100% Remote for the right candidate. Job Purpose Lead one or more Phase I-IV studies programming activities as per the project strategies. Work independently implementing and executing the programming and project standards to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. Work closely with internal partnering functions, stakeholders, and external functional service providers to ensure all the programming deliverables are delivered in a timely manner with high quality. Participate in and contribute to development of standard macros, libraries, processes and act as a team p...

Posted 1 week ago

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Lead Biostatistician Atorus

5.0 - 10.0 years

0 Lacs

india

Remote

remote from anywhere in India Full-time Job Overview The Lead Biostatistician is responsible for the overall statistical management of services for projects to assure high quality and on-time delivery in accordance with Atorus and/or sponsor standard operating procedures (SOPs), Good Clinical Practice (GCP), ICH Guidelines and sponsor requirements. Provides leadership and statistical expertise into clinical development plans, concepts, and protocols as well as conducts statistical analysis and validates and interprets statistical analysis results. Job Responsibilities Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for cl...

Posted 1 month 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

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 1 month 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 4 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 4 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 5 months ago

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