Job Description
Cytel Inc. (Cambridge, MA) is seeking Principal Clinical Programmers 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.
Minimum Requirements: Bachelor's degree in Statistics, Computer Science, Biotechnology, or a closely related field and 4 years of experience in Clinical (CDISC/SDTM) programming activities across various therapeutics areas in the Pharmaceutical/Biotechnology industry, including: 4 years of advanced SAS Programming experience; 4 years of experience working with clinical trials electronic data capture systems, updating the Controlled Terminologies / Codelist formats and using MedDRA and WHO dictionaries; and 3 years of experience providing leadership across various global cross-functional teams to support Clinical (CDISC/SDTM) data submission to regulatory agencies. To apply, contact emma.higgins@cytel.com with job ID 725 in subject line.