Software Engineer

• Develop, validate, and maintain analysis datasets (SDTM/ADaM), Tables, Listings, and Figures (TLFs) in support of clinical trial reporting using SAS and R.
• Design and implement data visualization dashboards in Power BI to support clinical development teams, safety monitoring, and cross-functional data reviews.
• Collaborate closely with biostatistics, data management, clinical operations, and other functional teams to ensure accurate, timely, and efficient programming deliverables.
• Contribute to the development, refinement, and documentation of standard macros, templates, and programming processes.
• Participate in the review of study protocols, CRFs, and statistical analysis plans (SAPs) to ensure alignment with data reporting and visualization strategies.
• Ensure compliance with CDISC standards (SDTM, ADaM) and applicable regulatory requirements (e.g., FDA, EMA).
• Provide technical mentorship and support to junior programmers and contribute to training initiatives.
• Lead or contribute to programming activities in support of regulatory submissions (e.g., define.xml, reviewer guides, data packages).

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