Clinical SAS Programmer Lead
VUEVERSE CONSULTING SERVICES
Position Summary :We are seeking an experienced Clinical SAS Programmer Lead to support Phase II-IV clinical studies and regulatory submissions. The ideal candidate will possess strong expertise in SAS programming, CDISC standards (SDTM/ADaM), TLF generation, and clinical trial data analysis. This role involves leading programming activities, collaborating with cross-functional teams and clients, mentoring junior programmers, and ensuring high-quality regulatory deliverables within project timelines.Key Responsibilities :- Lead programming activities for Phase II-IV clinical studies of simple to moderate complexity.- Develop, validate, and maintain SAS programs for data extraction, transformation, analysis, and reporting.- Generate and validate Tables, Listings, and Figures (TLFs) for clinical and safety reporting.- Create, validate, and deliver CDISC-compliant SDTM, ADaM, Define.xml, and aCRF deliverables.- Analyze and integrate data from multiple sources, including clinical databases, virtual trials, and wearable devices.- Support ISS, ISE, regulatory submissions, and responses to Regulatory Authority Questions (RTQs).- Collaborate with project teams, biostatisticians, data management, and client stakeholders.- Develop project timelines, estimate resources, monitor budgets, and ensure timely delivery.- Provide guidance and mentorship to junior programmers.- Contribute to SOP development, training materials, process improvements, and departmental initiatives.- Ensure compliance with CDISC standards and regulatory requirements across studies.- Support statistical safety reporting, safety event notifications, and data alert generation.Required Qualifications :- Bachelor's or Master's degree in Computer Science, Statistics, Biostatistics, Mathematics, or a related field.- 5+ years of clinical programming experience, preferably within a CRO environment.- Strong hands-on expertise in SAS programming.- End-to-end experience with CDISC SDTM, ADaM, and TLF development.- Strong understanding of relational databases and clinical data structures.- Experience supporting regulatory submissions, including ISS, ISE, and RTQs.- Expertise in at least two therapeutic areas, including Oncology.- Experience leading studies or programming teams.- Familiarity with Agile methodologies and ways of working.- Excellent communication and stakeholder management skills.- Fluency in English. (ref:hirist.tech)
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