Sr. Clinical Database Programmer/Analyst

Pulse Biosciences

3d

About The Position

The Sr. Clinical Database Programmer/Analyst is responsible for specifying, developing, validating, and executing databases related to clinical systems and applications within eClinical technologies. You will also be responsible for providing data management support to the Clinical Data Management team and Clinical Operations team.

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.

Responsibilities

• Creates and develops clinical databases and data transfer files according to written specifications.
• Develops and evaluates database configurations, including edit checks, derivations, and form/field dynamics in collaboration with Clinical Data Management.
• Troubleshoots complex database issues and analyzes data to identify trends and patterns.
• Handles pre-processing and loading of non-CRF data files.
• Assumes 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)
• Manages programming data exports from various sources, developing complex subject profiles/cohorts, and creating listings in multiple output formats like PDF and XML.
• Coordinates interim analyses, database snapshots, and final database lock, ensuring data integrity for regulatory filings and publications
• Assists with producing reports, tables, listings, and figures for clinical study reports (CSRs) and publications.
• Develops safety datasets for trial level reporting for submission to regulatory agencies.
• Creates high level presentations that represent clinical data outcomes for Clinical Affairs management on a monthly basis.
• Collaborates with the project team to ensure that deliverables are completed on time with high quality.
• Maintains all project documentation as required by SOP and Processes.

Benefits

• A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.
• Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.
• Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees