Senior Statistical Programmer (SDTM)

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.