Senior Clinical Analyst and Programmer - Remote

Overview

The Senior Clinical Analyst and Programmer will lead the programming activities for various purposes including different data listings to be used for data review, Safety Review Listings, Centralized Monitoring Listings and Reports. This role involves gathering, understanding, and analyzing needs reported by the Data Management and Risk Based Study Management departments, creating code to meet these needs within agreed timelines and budget, and ensuring conformance with regulatory requirements and industry guidelines.

In Short

• Create listing specifications based on user requirements from DM and RBSM.
• Create SAS Data Review Listings based on protocol and database specifications.
• Document changes to code and specifications.
• Assist in developing Standard Operating Procedures related to data standards.
• Mentor junior Analysts and Programmers.
• Develop strategies to increase productivity and quality.
• Participate in creating reports and listings for Centralized Monitoring.
• Maintain a library of Manual Data Review Listings.
• Ensure compliance with regulatory requirements.
• Work in a high-speed environment managing multiple competing demands.

Requirements

• Bachelor of Science degree required; Master’s degree in relevant fields is a plus.
• At least 10 years of clinical research experience, including 5 years of SAS programming.
• Excellent knowledge of regulatory requirements and drug development process.
• Strong project planning and time management skills.
• Effective verbal and written communication skills in English.
• Experience with clinical trial data and database specifications.
• SAS certification or Advanced Programmer experience is an asset.
• Detail-oriented and organized.

Benefits

• Flexible work schedule.
• Home-based position.
• Ongoing learning and development opportunities.
• Stimulating work environment.
• Attractive advancement opportunities.