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.
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 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.
Requirements:
- 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.
Benefits:
- 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.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
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