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Job Details

Job Summary

We are looking for an experienced Statistical Programmer with solid hands-on expertise in SAS programming and deep knowledge of CDISC standards, including SDTM and ADaM. This role will be responsible for independently developing, validating, and maintaining SAS/R programs including development of analysis datasets and production of TFLs to support clinical studies and regulatory submission deliverables, with oversight and guidance responsibilities. It requires a deep understanding of clinical trial design and data analysis.

Key Responsibilities

• Develop and validate datasets in compliance with dataset specifications following CDISC standards (SDTM and ADaM) and study requirements.




• Program, generate, and quality check TFLs for efficacy and safety analyses for clinical study report or regulatory submissions following SAP, mock shells and internal standards.
• Perform SAS and R statistical programming.
• Contribute to the preparation and review of programming deliverables across multiple studies or projects.
• Collaborate closely with Biostatistics, Data Management, Clinical, and other cross-functional teams to resolve data issues and support study objectives.
• Support creation and maintenance of programming documentation, specifications, and standard processes.
• Contribute to process improvements, standardization efforts, and development of reusable programming tools such as macros and templates.
• Ensure timely delivery of high-quality programming outputs in a fast-paced clinical development environment.
• Provide technical guidance and day-to-day support to ju

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