Senior Clinical Database Programmer/Analyst

Role Overview

• Create and develop clinical databases and data transfer files according to written specifications.
• Develop and evaluate database configurations, including edit checks, derivations, and form/field dynamics in collaboration with Clinical Data Management.
• Troubleshoot complex database issues and analyze data to identify trends and patterns.
• Handle pre-processing and loading of non-CRF data files.
• Assume responsibility for all DM activities (from study start-up to database lock) within project timelines including but not limited to data reviews, resolving data discrepancies, performing UAT, authoring/reviewing data management documentation (Data Management Plans, Data Review Guidelines, eCRFs, clinical database specifications and snapshot forms).
• Manage programming data exports from various sources, developing complex subject profiles/cohorts, and creating listings in multiple output formats like PDF and XML.
• Coordinate interim analyses, database snapshots, and final database lock, ensuring data integrity for regulatory filings and publications.
• Assist with producing reports, tables, listings, and figures for clinical study reports (CSRs) and publications.
• Develop safety datasets for trial level reporting for submission to regulatory agencies.
• Create high level presentations that represent clinical data outcomes for Clinical Affairs management on a monthly basis.
• Collaborate with the project team to ensure that deliverables are completed on time with high quality.
• Maintain all project documentation as required by SOP and Processes.

Requirements

• Bachelor’s degree in Computer Science, Informatics or a combination of education, training, and experience that provides the required knowledge
• Experience with SQL scripting/Clinical SAS programming is preferred
• EDC systems build expertise and custom function programming experience
• Knowledge of EU regulatory agencies, FDA/ISO guidelines, and industry standard practices regarding data management
• Demonstrate understanding of clinical data structures and communicate database design concepts to clinical study teams
• Demonstrated ability to produce clinical data deliverables
• Demonstrate strong analytical skills
• Flexibility and ability to manage multiple priorities simultaneously
• Ability to work independently and perform assigned tasks with minimal supervision
• Team player with strong verbal and written communication skills
• Demonstrated ability to learn new technologies, applications, and techniques
• Ability to review and understand medical/technical data
• Ability to articulate technical challenges internally and to external study-related personnel.
• Ability to lift 10-15 pounds.

Tech Stack

• SQL

Benefits

• A variety of health insurance plans and supplemental insurance options
• 401k retirement savings plan
• Paid time off
• Paid holidays
• Flexible work schedule
• Wellness program, including onsite gym and mindfulness classes
• Stock options awards
• Employee Stock Purchase Plan (ESPP) to share in our success
• A commitment to providing a respectful work environment to our diverse workforce.