Clinical SAS Programmer Lead

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. 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.