Statistical Programmer II (SDTM) in India at Jobgether

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 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.

• 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 timely delivery of project milestones.
• Follow clinical programming standards, regulatory expectations, and established quality processes throughout the development lifecycle.
• Contribute to process improvements and share technical knowledge to strengthen programming practices and project delivery.

• Bachelor’s or Master’s degree in Life Sciences, Computer Science, Pharmacy, or another relevant discipline, or equivalent professional experience.
• At least 3 years of experience in SDTM statistical programming within clinical research or another regulated environment.
• Strong working knowledge of SAS and clinical programming and reporting processes.
• Demonstrated experience developing SDTM Trial Design domains and complex SDTM datasets.
• Understanding of regulatory requirements and industry technical standards relevant to clinical trial data.
• Familiarity with SDTM methodologies, clinical data processes, programming standards, and regulatory submission requirements.
• Understanding of efficacy endpoints and clinical efficacy concepts, with exposure to methodologies such as RECIST or IMWG considered valuable.
• Strong analytical and problem-solving abilities, with a careful and quality-focused approach to programming.
• Excellent written and verbal communication skills, including strong proficiency in English.
• Strong organizational and project management skills, with the ability to manage competing priorities and adapt to changing requirements.
• Ability to collaborate effectively with internal and external stakeholders across global, cross-functional teams.
• Experience supporting an SDTM Lead on clinical research studies is a plus.

• Full-time remote position based in India, with Hyderabad identified as the primary location.
• Opportunity to work on clinical research programs supporting the development of new therapies.
• Exposure to global sponsors, cross-functional teams, and complex clinical development projects.
• Opportunities to strengthen expertise in SDTM, SAS programming, regulatory standards, and clinical data processes.
• Growth and continuous learning opportunities within statistical programming and clinical development.
• Collaborative, quality-focused, and innovation-oriented working environment.
• Opportunity to contribute to process improvements and develop broader technical and project delivery expertise.