Clinical programmer for Ph3 program & global regulatory submissions Oversight of clinical program, ensuring quality and achieving timelines for programming activities
Develop and maintain SAS programs and other programming tools required for data analysis, reporting, and visualization, using industry best practices and standards
Review and validate clinical data to ensure quality and consistency and identify and resolve data discrepancies and issues
Help develop and implement organizational best practices Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business Ad hoc programming activities for cross functional colleagues
Development and Maintenance of internal databases
Participate in the development and implementation of processes and tools to improve the efficiency and quality of programming activities and ensure compliance with regulatory requirements/industry standards Advanced graphical production
Contribute to the preparation of clinical study reports, regulatory submissions, and other clinical trial-related documents.
Provide technical guidance and leadership to the programming team, including mentoring and training, and participate in performance evaluations and career development discussions
Requirements Education: BS Required; MS Preferred
Experience:
6+ years SAS and CDISC experience required Phase 3 experience
Skills/Abilities:
Proven ability to meet strict deadlines.
Manage competing priorities and ability to be flexible and receptive to changing demands.
Excellent organizational skills and time management skills