This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Statistical Programmer (SDTM) based in India.
This is a senior-level statistical programming opportunity supporting clinical research and the delivery of high-quality clinical trial data and reporting solutions.
You will provide technical expertise across SDTM programming, clinical data standards, study start-up, and data mapping activities.
The role offers the opportunity to serve as an SDTM Lead or Statistical Programming Coordinator on complex clinical research projects.
You’ll collaborate with biostatisticians, data operations teams, sponsors, and other global stakeholders to ensure accurate and timely study delivery.
Your work will contribute to regulatory-compliant clinical development programs and ultimately support the advancement of new therapies.
The environment is fast-paced and highly regulated, with a strong emphasis on quality, technical excellence, collaboration, and continuous improvement.
This role also provides opportunities to mentor colleagues, improve programming processes, and strengthen your expertise across clinical development.
Accountabilities
- Serve as an SDTM Lead on clinical research studies, providing technical direction and ensuring high-quality SDTM deliverables.
- Program and deliver complex SDTM datasets in accordance with study requirements and applicable clinical data standards.
- Develop and review SDTM Trial Design domains and related mapping specifications.
- Coordinate study and project start-up activities, ensuring programming requirements and deliverables are clearly defined and implemented.
- Review clinical study protocols and Statistical Analysis Plans (SAPs), providing informed recommendations on SDTM mapping strategies and implementation.
- Perform programming, quality control, troubleshooting, and debugging activities, including work with moderately complex SAS macros.
- Support clinical study analysis and reporting activities, including data import/export programming and other statistical programming deliverables.
- Apply knowledge of efficacy endpoints and assessment methodologies, including RECIST and IMWG, when relevant to study programming activities.
- Ensure programming activities comply with applicable CDISC standards, ICH-GCP principles, regulatory requirements, and established quality processes.
- Collaborate with sponsors, biostatisticians, Data Operations Leads, and cross-functional teams to resolve technical issues and maintain project timelines.
- Identify opportunities to improve programming processes, develop reusable macros or applications, and increase efficiency and consistency.
- Provide technical guidance, mentoring, and training to other team members where appropriate.
- Contribute to continuous improvement initiatives and support high standards of quality management across clinical programming activities.
Requirements
- Degree in a relevant discipline or equivalent professional experience.
- Relevant experience within the clinical trials, pharmaceutical, biotechnology, CRO, or another highly regulated environment.
- Strong hands-on SAS programming skills and solid knowledge of statistical programming and clinical reporting processes.
- Demonstrated experience working as an SDTM Lead, Statistical Programming Coordinator, or study/project lead on clinical research projects.
- Proven experience developing complex SDTM datasets and working with SDTM Trial Design domains.
- Strong knowledge of CDISC standards, SDTM mapping, mapping specifications, and regulatory submission requirements.
- Experience reviewing clinical protocols and SAPs and translating study requirements into appropriate SDTM strategies.
- Understanding of efficacy endpoints and assessment methodologies, including RECIST and IMWG.
- Knowledge of ICH-GCP, 21 CFR Part 11, regulatory requirements, System Life Cycle methodologies, and relevant industry technical standards.
- Experience troubleshooting and debugging SAS macros of moderate complexity.
- Strong technical problem-solving skills, attention to detail, and a consistent focus on data quality and compliance.
- Excellent written and verbal English communication skills, with the ability to work effectively with internal and external stakeholders.
- Strong organizational and project-management skills, including the ability to manage competing priorities and meet deadlines.
- Ability to work collaboratively across global, cross-functional teams while also operating independently.
- 5+ years of experience in statistical programming coordination or study leadership is preferred.
- Experience developing standard macros, applications, or other programming solutions that improve efficiency is advantageous.
- Experience mentoring, training, or providing technical guidance to colleagues is a plus.
Benefits
- Full-time, remote working opportunity in India.
- Opportunity to contribute to global clinical research and programs supporting the development of new therapies.
- Exposure to complex clinical studies, international stakeholders, and diverse therapeutic and regulatory environments.
- Opportunities to strengthen expertise in SAS, SDTM, CDISC standards, and clinical data programming.
- Potential to take on technical leadership and study coordination responsibilities.
- Opportunities for mentoring, knowledge sharing, and professional development.
- Collaborative environment with global cross-functional teams.
- Opportunity to contribute to process improvements, programming efficiencies, and innovative clinical research solutions.
- Work within a quality-focused and highly regulated environment that values technical excellence, teamwork, and continuous learning.
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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