Pulse Biosciences, Inc.

Senior Clinical Database Programmer/Analyst

Pulse Biosciences, Inc.

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

Tech Stack

SQL

About the role

  • 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.
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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SQL scriptingClinical SAS programmingEDC systems buildcustom function programmingdata management documentationdata reviewsdata discrepancies resolutionUATclinical database specificationssafety datasets development
Soft Skills
analytical skillsflexibilityability to manage multiple prioritiesindependenceteam playerverbal communicationwritten communicationability to learn new technologiesability to articulate technical challengesability to review medical/technical data