Principal Statistical Programmer Consultant – Oncology

September 6

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ClinChoice

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Biotechnology • Pharmaceuticals • Healthcare Insurance

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.

1001 - 5000 employees

Founded 1998

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Support Programming deliveries of a clinical study or project • Implement statistical programming aspects of the protocol and the clinical development program • Ensure high quality is built into own deliverables and those of other programmers • Program independently with high efficiency and quality • Write and/or implement specifications and oversee completeness of relevant documentation • Contribute to development of best practices to improve quality, efficiency, and effectiveness • Ensure compliance with standards and automation usage • Plan and support team activities and tasks • Communicate and escalate risks within assigned studies and/or projects • Work proactively with study team members including Statistician, Lead Programmer, Data Manager and Study Leader • Act as a client-facing consultant establishing a high-trust environment with client counterparts

🎯 Requirements

• Bachelor’s degree in computer science, statistics, or related scientific discipline with 5 years clinical programming (CDISC) experience • Master’s degree in CS, statistics or related disciplines with 6 years clinical programming (CDISC) experience • Oncology therapeutic area (TA) experience • Working knowledge of ICH and Good Clinical Practices (GCP) • Knowledge of clinical research, clinical trial process, and related regulatory requirements and terminology • Good understanding of the clinical drug development process • Strong communication 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 • Ability to work independently and in a client-facing capacity

🏖️ Benefits

• Security and additional career opportunities from working for a global CRO • Strong focus on professional development • Supportive culture • Close management and continuous training to maintain competence and expertise • Equal opportunity employer