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. The Senior Clinical Analyst and Programmer will be responsible to gather, understand and analyze the needs reported by the Data Management (DM) and Risk Based Study Management (RBSM) departments, and to create code to answer these needs within agreed timelines and budget. This person will assist with development and maintenance of optimal strategies to increase productivity and quality, while decreasing cycle times and costs. In addition, the Senior Clinical Analyst and Programmer is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Indero standard operating procedures (SOPs) while respecting Indero’s commitment to sponsor’s requirements and timelines.

In Short

• Create listing specifications based on user requirements mainly from DM and RBSM.
• Create SAS Data Review Listings, based on protocol, EDC Database and Data Validation Specs.
• Create a library of Manual Data Review Listings.
• Create Safety Review Listings.
• Actively participates in creating reports and listings to support Centralized Monitoring.
• Document changes to code and specifications.
• Assist in the development of Standard Operating Procedures (SOPs) related to the implementation of data standards.
• Assist with development and maintenance of strategies to increase productivity and quality, while decreasing cycle times and costs.
• Serve as a mentor to more junior Analysts and Programmers.

Requirements

• A Bachelor of Science degree is required;
• Master's degree in Computer Science, Information Technology Systems, Statistics, Engineering, or a related field, an asset;
• At least 10 years of clinical research experience in the biotechnology, pharmacy or CRO industry, including 5 years of SAS programming;
• Excellent knowledge of regulatory requirements and the drug development process;
• Extended exposure to clinical trial data, SAS data, and database specifications;
• SAS certification and / or Advance Programmer experience would be assets;
• Very organized and focused on details, with effective project planning and time management skills;
• Strong verbal and written communication skills in English;
• Ability to work in a high-speed environment with proven agility to juggle and prioritize multiple competing demands;

Benefits

• Flexible work schedule
• Home-based position
• Ongoing learning and development