Responsibilities:
• Responsible for supporting the Programming deliveries of a clinical study or project.
• Implements statistical programming aspects of the protocol and the clinical development program.
• Ensures high quality is built into own deliverables and the quality delivered by other programmers.
• Programs independently with high efficiency and quality.
• Writes and/or implements specifications and oversees completeness of relevant documentation.
• Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
• Ensures compliance with standards and automation usage.
• Plans and support team activities and tasks.
• Communicates and escalates risks within the assigned studies and/or projects.
• Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader.
Requirements:
• Bachelor's degree in computer science (CS), statistics, or related scientific disciplines with 8 yrs. of clinical programming (CDISC) experience; (or) Master's degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience.
• Need to have Oncology/Hematology TA experience.
• Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.
• Good understanding of the clinical drug development process.
• Strong communication skills and coordination skills.
• Current knowledge of technical and regulatory requirements relevant for the role.
• Ability to proactively manage concurrent activities within a project.
• Proficient ability to influence relevant stakeholders on programming-related.
Location: South Plainfield, NJ
Posted: Oct. 4, 2024, 8:44 p.m.
Apply Now Company Website