Overview • Serve as a lead statistical programmer for complex clinical trial projects. • Develop and validate SAS programs for clinical study analysis and reporting. • Collaborate with cross-functional teams to ensure programming deliverables meet quality standards. • Contribute to statistical analysis plans and regulatory submission documentation. • Provide technical expertise in CDISC standards and regulatory requirements. • Mentor programming staff and lead training initiatives within the department. • Manage programming schedules and priorities across multiple projects. • Participate in sponsor meetings and provide programming insights. • Support innovation and standardization efforts within the Biostatistics Department. Key Responsibilities & Duties • Develop SAS programs to generate summary tables, data listings, and derived datasets. • Validate programming outputs and resolve discrepancies with team collaboration. • Ensure adherence to SOPs, work instructions, and regulatory guidelines. • Maintain organized project documentation for inspection readiness. • Define programming strategies and manage project metrics effectively. • Lead statistical programming activities and coordinate team efforts. • Review and provide feedback on study documentation and specifications. • Mentor and train programming staff on clinical trial processes and standards. • Contribute to the development of programming tools and macros for efficiency. Job Requirements • Bachelor’s degree in a scientific or statistical discipline or equivalent experience. • Minimum of 5 years of SAS programming experience in clinical trials. • Proficiency in CDISC standards and regulatory submission processes. • Demonstrated ability to lead complex programming projects and teams. • Strong written and verbal communication skills in English. • Experience mentoring and training programming staff. • Knowledge of clinical drug development and industry standards. • Ability to manage multiple projects and adapt to changing priorities. • Technical expertise in SAS programming and clinical trial analysis.