Principal Statistical Programmer - Late Phase - Consulting

5 days ago

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ClinChoice

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Full-Service CRO • Clinical Development • Post-Marketing & Real-World Evidence • Quality and Compliance • Technology

1001 - 5000

Description

• Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. • ClinChoice is searching for a Principal/Statistical Programmer Analyst/Consultant to join one of our clients. • ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. • The Senior Statistical Programmer Analyst/Consultant is a delivery-focused role who works under the leadership, oversight, and direction of a Programming team leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks • 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 6 yrs. of clinical programming (CDISC) experience; Master’s degree in CS, statistics or related disciplines with 7 yrs. of clinical programming (CDISC) experience. • Need to have Oncology 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 items