Statistical Programmer II (SDTM)

📋 Description

• Review protocols and SAPs; provide SDTM mapping feedback.
• Develop SDTM trial design domains; program SDTM datasets.
• Quality-focused SAS programming; deliver reliable clinical data deliverables.
• Debug macros; improve programming efficiency and consistency.
• Support SDTM Leads with project coordination and daily deliverables.
• Assist with study start-up activities and regulatory submission prep.

🎯 Requirements

• Bachelor’s or Master’s in Life Sciences, CS, Pharmacy, or equivalent experience.
• At least 3 years SDTM statistical programming in clinical research or regulated environment.
• Strong SAS programming knowledge; clinical reporting processes.
• Experience developing SDTM Trial Design domains and complex datasets.
• Understanding of regulatory requirements and industry standards for clinical data.
• Familiarity with SDTM methodologies and submission requirements.

🎁 Benefits

• Full-time remote position based in India, Hyderabad identified as primary location.
• Opportunity to work on clinical research programs for new therapies.
• Exposure to global sponsors and complex development projects.
• Strengthen SDTM, SAS programming, regulatory standards, and data processes.
• Growth and continuous learning in statistical programming and clinical development.
• Collaborative, quality-focused, innovative environment.