Lead Statistical Programmer Consultant - Hematology - Clinical Trials

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 Programmer Analyst/Consultant to join one of our clients in Hematology TA Team. • 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 Principal Statistical Programmer consultant will lead and support all programming activities per the project strategies and should be able to work independently implementing and driving the programming to support ongoing clinical studies and requests for study report and regulatory submission. • This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks. • Develop Tables, Figures, Listings (TFLs) deliverables from existing SAS programs for Clinical Study Report (CSR) if similar TFLs exist and from scratch for new outputs. • Capacity for independent programming and review of reports and outputs. • Customize outputs and graphics according to delivery specifications of target audience on the direction of biostatisticians. • Responsible for supporting the Programming deliveries of a clinical study or project. • Programs independently with high efficiency and quality. • 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.

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 8 yrs. of clinical programming (CDISC) experience. • Oncology/Hematology TA experience is required. • ISS & ISE experience is required. • 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