Principal Clinical Programmer

Cytel; Salt Lake City (UT); Remote; USD 110,000 - 150,000; Full time

Job summary

Cytel Inc. is seeking a Principal Clinical Programmer to work remotely, leading clinical programming projects and ensuring compliance with regulatory standards. The role involves quality control, mentoring team members, and generating critical data for submissions. Candidates should possess advanced SAS programming skills and a solid understanding of regulatory requirements. This is a fully remote position based in Salt Lake City, UT.

Qualifications

• Strong SAS programming skills required.
• Leadership and mentoring experience necessary.
• Understanding of regulatory requirements crucial.

Responsibilities

• Lead clinical programming projects and ensure audit readiness.
• Mentor and train programming staff.
• Generate submission-ready SDTM packages.

Skills

SAS programming

quality control

leadership

regulatory compliance

Job description

Cytel Inc. seeks Principal Clinical Programmers in Cambridge, MA to use advanced SAS programming skills to lead clinical programming projects and to ensure the clinical programming systems, processes, and deliverables are aligned with the relevant regulatory requirements. Responsible for quality control and audit readiness of all assigned Clinical programming deliverables as well as accuracy and reliability of deliverables. Monitor quality, timelines, resource allocation, and productivity in relation to budgets and ensure audit readiness for all tasks. Provide mentoring and training to clinical programming staff members. Conduct briefings and participate in technical meetings for internal and external representatives. Generate and review internal data and / or SDTM datasets using internal conversion framework, utilities, and global checks. Lead, and / or oversee programming of, quality review checks and reports for use by Data Managers and other team members. Responsible for creation of submission-ready SDTM packages for FDA / PMDA or other regulatory authority submissions and keeping abreast in changing regulatory requirements. 100% telecommuting. To apply, submit resume at

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

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Clinical Programmer • Salt Lake City, UT, United States