Statistical Programmer

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 based in India.

This role plays a key part in supporting clinical research by transforming complex clinical trial data into high-quality statistical outputs used for regulatory submissions, study reporting, and decision-making. You will be responsible for programming and validating SDTM and ADaM datasets, as well as generating tables, listings, and figures (TLFs) that support clinical study reports and interim analyses. The position requires close collaboration with biostatistics, data management, and cross-functional clinical teams to ensure accuracy, compliance, and consistency across deliverables. You will also contribute to data cleaning activities and help enhance programming efficiency through standardized SAS macros and automation initiatives. The environment is highly regulated, detail-oriented, and quality-driven, requiring adherence to global standards such as CDISC, ICH, and regulatory guidelines. This is a great opportunity for professionals looking to grow within clinical research and contribute to impactful pharmaceutical and biotech studies.

• Develop, maintain, and validate annotated Case Report Forms (aCRFs), SDTM and ADaM datasets, and statistical outputs including Tables, Listings, and Figures (TLFs) across clinical studies.
• Program and validate datasets and deliverables in alignment with CDISC standards (SDTM/ADaM), study protocols, and statistical analysis plans.
• Support data management activities by assisting in data cleaning, issue tracking, and resolution in collaboration with biostatistics and programming teams.
• Generate and maintain define.xml files, reviewer guides, and related documentation in compliance with regulatory submission standards.
• Apply SAS programming and global macros to improve efficiency and ensure consistency in statistical programming deliverables.
• Validate SDTM and ADaM datasets using Pinnacle 21 and ensure resolution of all identified issues.
• Contribute to the development and improvement of internal programming standards, templates, and automation tools.
• Collaborate with cross-functional teams to ensure timely, high-quality deliverables aligned with project timelines and budgets.
• Stay updated on regulatory requirements, CDISC standards, and industry best practices in clinical programming.

Requirements:

• Bachelor’s degree in Statistics, Computer Science, or a related field; Master’s degree is an advantage.
• Minimum 1 year of experience in clinical research within pharmaceutical, biotech, or CRO environments, including hands-on statistical programming experience.
• Strong proficiency in SAS programming; SAS certification is a plus.
• Solid understanding of CDISC standards (SDTM, ADaM) and clinical data submission requirements.
• Familiarity with clinical trial processes, SAPs, TLF shells, and regulatory guidelines (ICH, FDA, Health Canada).
• Knowledge of XML programming and Pinnacle 21 validation tools is an advantage.
• Strong attention to detail, organization, and ability to manage multiple priorities in a fast-paced environment.
• Ability to work independently as well as collaboratively in cross-functional teams.
• Strong written and verbal communication skills in English; French is an advantage.

Benefits:

• Permanent full-time remote position with flexibility in work location (India-based eligibility required).
• Flexible working schedule supporting work-life balance.
• Opportunity to work in a specialized global clinical research organization focused on dermatology studies.
• Continuous learning and professional development opportunities in clinical programming and statistical methodologies.
• Exposure to international regulatory standards and global clinical trial environments.
• Collaborative and knowledge-driven work culture with strong career growth potential.