3.0 - 8.0 years

5 - 15 Lacs

new delhi, pune, delhi / ncr

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Role & responsibilities Contribute to the design and implementation of AI augmented clinical data products (Protocol, ICF, CSR, etc.) and GxP-validated content generation for SDTM, ADaM, and TLG. Support development of Agentic AI solutions for specifications, data mapping, and metadata-driven workflows. Assist in delivering analysis-ready datasets for submission use cases. Collaborate in Agile projects, documenting requirements, writing user stories, and maintaining backlogs using JIRA/Retina. Participate in requirement discussions, creation of specifications, traceability, and user guides aligned with regulatory compliance. Engage with cross-functional teams to support AI-driven biometrics ...

Posted 3 months ago

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Top MNC Hiring - Expert Biostatistician Navayuga Consultancy

10.0 - 17.0 years

16 - 25 Lacs

Kolkata, Mumbai, Chennai

Work from Office

Select the apt sample size; collect data; perform the test; and develop TLG (tables, listings, and graphs); and finally, report the inference. Review of ADaM Specifications and TLGs. Develop statistical analysis plans (SAPs) in alignment with clinical protocols and regulatory guidelines (ICH, FDA, EMA). Perform and validate complex statistical analyses using SAS and R , ensuring accuracy and reproducibility. Provide statistical input into clinical study design, sample size calculation, randomization, and data collection strategies. Collaborate closely with Clinical, Data Management, Medical Writing, and Regulatory Affairs teams. Present and interpret statistical findings to non-technical sta...

Posted 7 months ago

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Clinical SAS Programmer Glenmark Pharmaceuticals

13 - 18 years

30 - 45 Lacs

Navi Mumbai

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Job Description :SAS Programmer ABOUT GLENMARK Glenmark Pharmaceuticals Ltd. is an innovation-driven global pharmaceutical company with a presence across Specialty, Generics and OTC businesses. It focuses on the key therapeutic areas of respiratory, dermatology and oncology. The company has 11 world-class manufacturing facilities, 4 research and development centers, spread across 5 continents and operations in over 80 countries. Glenmark is ranked among the world's top 100 biopharmaceutical companies (Top 100 Companies Ranked by Pharmaceutical R&D and Sales, 2022, by In Vivo/Scrip 100) and among the world's top 50 companies in the Generics and Biosimilars (Top 50 Generics and Biosimilars Com...

Posted 7 months ago

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