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Sr. Clinical Database Programmer/Analyst

21 hours, 30 minutes ago
United States
Full-time
Senior
Database Administrator
Data Science and Analytics
SQL XML
Apply Now
Pulse Biosciences

Pulse Biosciences

Powering the next generation in bioelectric medicine with Nanosecond Pulse Field Ablation technology. Pulse Biosciences pioneers in the research, design and production of our patented Nanosecond Pulsed Field Ablation™ (nsPFA™) technology for use in hig...

Health Care Providers & Services
51-250
Founded 2016
$80M raised
View All Jobs 2

Description

  • Specify, develop, validate, and execute clinical databases and related data transfer files within eClinical technologies.
  • Create and develop clinical databases 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.
  • Own data management activities from study start-up through database lock, including data review, discrepancy resolution, UAT, and documentation authoring/review.
  • Manage programming data exports, subject profiles/cohorts, and listings in multiple output formats such as PDF and XML.
  • Coordinate interim analyses, database snapshots, and final database lock to support data integrity for regulatory filings and publications.
  • Assist with reports, tables, listings, and figures for clinical study reports and publications.
  • Develop safety datasets for trial-level reporting to regulatory agencies.
  • Create high-level presentations on clinical data outcomes for Clinical Affairs management.
  • Collaborate with project teams to ensure deliverables are completed on time and with high quality.
  • Maintain project documentation in accordance with SOPs and internal processes.

Requirements

  • Bachelor’s degree in Computer Science, Informatics, or an equivalent combination of education, training, and experience.
  • Experience with SQL scripting or Clinical SAS programming is preferred.
  • Experience building EDC systems and programming custom functions.
  • Knowledge of EU regulatory agencies, FDA/ISO guidelines, and industry-standard data management practices.
  • Understanding of clinical data structures and ability to communicate database design concepts to clinical study teams.
  • Demonstrated ability to produce clinical data deliverables.
  • Strong analytical skills.
  • Ability to manage multiple priorities simultaneously and work independently with minimal supervision.
  • Strong verbal and written communication skills and ability to work as part of a team.
  • Ability to learn new technologies, applications, and techniques.
  • Ability to review and understand medical and technical data.
  • Ability to articulate technical challenges to internal and external study-related personnel.
  • Ability to lift 10-15 pounds.

Benefits

  • Variety of health insurance plans and supplemental insurance options.
  • 401(k) retirement savings plan.
  • Stock option awards and Employee Stock Purchase Plan (ESPP).
  • Paid time off and paid holidays.
  • Flexible work schedule.
  • Wellness program, including an onsite gym and mindfulness classes.
  • Learning culture with professional and personal growth opportunities.
  • Respectful, inclusive work environment.

Interested in this position?

Apply directly on the company website

Apply Now

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