Senior Statistical Programmer

Position Summary

We are seeking an experienced Clinical SAS Programmer Lead to support Phase IIIV 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 IIIV 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

• Bachelors or Masters 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.