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 setting is collaborative, 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.
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 iss
📌 Statistical Programmer II (India)
🏢 Jobgether
📍 India
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