Pulse Biosciences, Inc.

Software Engineer

• 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.

Senior Clinical Database Programmer/Analyst