Clinchoice - Boston, KY
posted 8 days ago
Full-time - Senior
Boston, KY
1,001-5,000 employees
Administrative and Support Services
About the position
The Lead/Principal Statistical Programmer Consultant at ClinChoice is a client-facing role focused on leading programming activities for clinical studies in the Hematology therapeutic area. This position requires a high level of technical expertise and the ability to work independently while fostering a collaborative environment with clients. The consultant will be responsible for developing statistical outputs, ensuring compliance with industry standards, and contributing to best practices within the programming function.
Responsibilities
- Develop Tables, Figures, Listings (TFLs) deliverables from existing SAS programs for Clinical Study Reports (CSR) and create new outputs from scratch.
- Independently program and review reports and outputs with high efficiency and quality.
- Customize outputs and graphics according to delivery specifications based on biostatisticians' direction.
- Support the Programming deliveries of clinical studies or projects.
- Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
- Ensure compliance with standards and automation usage.
- Plan and support team activities and tasks.
- Communicate and escalate risks within assigned studies and/or projects.
Requirements
- Bachelor's degree in computer science, statistics, or related scientific disciplines with 6 years of clinical programming (CDISC) experience; or a Master's degree with 8 years of experience.
- Oncology/Hematology therapeutic area experience is required.
- Experience with ISS & ISE is required.
- Working knowledge of ICH and Good Clinical Practices, clinical research, clinical trial processes, and related regulatory requirements.
- 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.
