This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Statistical Programmer II (SDTM) based in India.
This is an opportunity to contribute to clinical research by developing and quality-controlling SDTM datasets that support regulatory submissions and important study decisions. You’ll work remotely with sponsors, data operations teams, SDTM leads, and other cross-functional stakeholders to deliver accurate, compliant clinical data. The role combines hands-on SAS programming with SDTM mapping, trial design domain development, and dataset programming. You’ll also contribute to submission preparation and process improvements through efficient programming practices. The environment is team-oriented, fast-paced, and focused on quality and operational excellence. This role offers strong opportunities to deepen your expertise in clinical data standards and grow within statistical programming and clinical development.
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Accountabilities:
Review clinical study protocols and Statistical Analysis Plans (SAPs),



providing relevant feedback on SDTM mapping strategies and implementation.
Develop SDTM Trial Design domains and program complex SDTM datasets in accordance with applicable standards and specifications.
Perform quality-focused programming activities using SAS and support the development of accurate, reliable clinical data deliverables.
Debug simple to moderately complex macros and contribute to improving programming efficiency and consistency.
Support SDTM Leads with study activities, project coordination, and day-to-day statistical programming deliverables.
Assist with clinical study start-up activities and contribute to the preparation of regulatory submission packages.
Apply knowledge of efficacy endpoints and assessment concepts, including areas such as RECIST and IMWG, where relevant.
Collaborate with sponsors, Data Operations Leads, and cross-functional teams to resolve issues and ensure

📌 Statistical Programmer II (India)
🏢 Jobgether
📍 India