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. 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 ma