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About the role
Key Responsibilities: - Develop, validate, and maintain SAS programs for clinical trial data analysis. - Generate Tables, Listings, and Figures (TLFs) based on Statistical Analysis Plans (SAPs). - Create SDTM and ADaM datasets in compliance with CDISC standards. - Perform data validation and quality checks to ensure programming accuracy and data integrity. - Collaborate with Biostatistics, Data Management, and Clinical Operations teams. - Troubleshoot programming issues and provide timely solutions. - Maintain programming documentation in accordance with SOPs and regulatory requirements. Required Qualifications: - Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field. - 2-3 years of statistical programming experience in the pharmaceutical, biotechnology, CRO, or IT industry. - Strong proficiency in SAS (Base SAS, SAS Macro, and PROC SQL). - Experience in TLF programming and generation. - Valuable understanding of CDISC standards, including SDTM and ADaM. - Familiarity with ICH-GCP guidelines and regulatory requirements (FDA, EMA). - Knowledge of clinical trial processes and statistical concepts. Preferred Skills: - Strong analytical and problem-solving abilities. - Excellent attention to detail. - Good communication and technical documentation skills. - Ability to work independently as well as in cross-functional teams. - Effective time management and multitasking capabilities. Technical Skills: - SAS (Base SAS, Macro Programming, PROC SQL) - TLF Programming - CDISC SDTM & ADaM - Microsoft Excel Nice-to-Have Skills: - Knowledge of R programming. - Experience with Define.xml generation. - Exposure to regulatory submissions (eCTD). - Understanding of clinical trial data management and EDC systems. Experience - 2-3 years of relevant statistical programming experience in clinical research. Location - PAN India .
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