ClinChoice
ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.
Full-Service CRO • Clinical Development • Post-Marketing & Real-World Evidence • Quality and Compliance • Technology
Lead Statistical Programmer Consultant - Hematology
October 20, 2024
ClinChoice
ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.
Full-Service CRO • Clinical Development • Post-Marketing & Real-World Evidence • Quality and Compliance • Technology
📋 Description
• ClinChoice is searching for a Principal Statistical Programmer Consultant to join one of our clients in Hematology Team. • The Principal Statistical Programmer consultant will lead and support all programming activities per the project strategies and should be able to work independently to implement and drive the programming to support ongoing clinical studies and requests for study reports and regulatory submissions. • 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). • Capacity for independent programming and review of reports and outputs. • Customize outputs and graphics according to delivery specifications of the 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. • Ensures compliance with standards and automation usage. • Plans and supports 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 8 yrs. of clinical programming (CDISC) experience; Master’s degree in CS, statistics or related disciplines with 7 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
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