This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the programming deliveries for a clinical study or project.

• Execute statistical programming components of protocols and clinical development initiatives.

• Maintain high standards in personal and team deliverables.

• Program independently with a focus on both efficiency and quality.

• Draft or execute specifications and ensure the completeness of relevant documentation.

• Contribute to best practices that enhance quality, efficiency, and effectiveness.

• Ensure adherence to standards and the utilization of automation tools.

• Organize and support team activities and responsibilities.

• Communicate and escalate risks associated with assigned studies or projects.

• Collaborate proactively with Statisticians, Lead Programmers, Data Managers, and Study Leaders.

⛳️ Requirements

• Bachelor’s degree in computer science, statistics, or related scientific fields with 5 years of clinical programming (CDISC) experience, or a Master’s degree in CS, statistics, or related fields with 6 years of clinical programming (CDISC) experience.

• Experience in the oncology therapeutic area.

• Familiarity with ICH guidelines and Good Clinical Practices, as well as clinical research, clinical trial processes, and associated regulatory requirements and terminology.

• Solid understanding of the clinical drug development process.

• Excellent communication and coordination abilities.

• Up-to-date knowledge of the technical and regulatory requirements pertinent to the role.

• Capability to proactively manage multiple project activities simultaneously.

• Skill in influencing relevant stakeholders on programming-related matters.