Senior Statistical Programmer - Remote

Key Responsibilities

• Provide programming support for the delivery of clinical studies and projects.
• Execute statistical programming components in alignment with study protocols and the overall clinical development strategy.
• Ensure high-quality outputs in personal deliverables and guide quality standards across the programming team.
• Perform independent programming tasks efficiently while maintaining strong quality standards.
• Develop, review, and implement programming specifications, ensuring all required documentation is accurate and complete.
• Contribute to the establishment and enhancement of best practices to improve efficiency, quality, and productivity within the programming function.
• Maintain compliance with applicable standards and leverage automation where appropriate.
• Plan, coordinate, and support team activities and assigned tasks.
• Proactively identify, communicate, and escalate risks related to studies or projects.
• Collaborate closely with cross-functional team members, including Statisticians, Lead Programmers, Data Managers, and Study Leaders.

Education and Experience

• Bachelor’s degree in Statistics, or a related scientific field with a minimum of 5 years of clinical programming experience using CDISC standards.
• Abundant experience with SDTM Implementation and ADaM implementation according to CDISC Standards.
• Solid understanding of ICH guidelines, Good Clinical Practice (GCP), clinical research principles, and regulatory requirements.
• Strong knowledge of the end-to-end clinical drug development lifecycle.
• Effective communication and collaboration skills, with the ability to coordinate across teams.
• Up-to-date knowledge of technical and regulatory expectations relevant to clinical programming.
• Demonstrated ability to manage multiple activities simultaneously within project timelines.
• Proven capability to influence stakeholders on programming-related decisions and deliverables.