Senior Clinical Data Associate, Clinical Programmer

6 days ago

California, United States Bayside Solutions Full time
Job Summary

We are seeking a highly skilled Senior Clinical Data Associate, Clinical Programmer to join our team at Bayside Solutions, Inc. This individual will be responsible for designing, writing, validating, and maintaining software to meet specifications in a timely and productive manner.

Key Responsibilities
  • Software Development: Utilize primary development tools, including SAS, R, and other supporting tools, to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures.
  • Documentation Management: Generate and maintain all required documentation supporting import setup and processing, export setup and processing, listings, and custom reports.
  • Data Transfer and Reconciliation: Manage internal and external data transfer processes and reconcile data from multiple sources to facilitate reporting outputs as defined in Clinical Data Management (CDM) documents.
  • Project Coordination: Serve on project teams to coordinate and lead development activities for clinical programming projects. Attend meetings, participate in discussions, use an analytical problem-solving approach, focus on deliverables, and share constructive feedback.
  • Application Administration: Provide application administration and technical support on core business packages including but not limited to SAS, R, and Medidata Rave.
  • Technical Support: Provide technological support to the Clinical Programming staff, Data Managers, and other teams.
  • Quality Assurance: Ensure high-quality deliverables by providing peer review of study level/program level outputs for accuracy.
  • Leadership: Lead Clinical Programming activities on 2 or more concurrent studies depending upon scope, similarity, program, and resourcing requirements.
  • Process Documentation: Review and write process documentation (SOPs and Wis) as needed.
  • Clinical Data Management: Contribute to developing Clinical Data Management (CDM) documents, including the Data Management Plan (DMP), output specifications, and data transfer processes.
  • Initiatives and Innovations: Offer input into initiatives, new technologies, and innovations to improve CDM processes; represent Clinical Programming through working groups and initiatives.
Requirements and Qualifications
  • Education: Bachelor's degree preferred; alternatively, an equivalent combination of education and experience.
  • Experience: 3+ years of relevant experience as a SAS or R programmer in drug research and development.
  • Communication and Interpersonal Skills: Excellent communication and interpersonal skills, both written and spoken, with an ability to inform.
  • Priority Management: Demonstrated experience in managing multiple priorities in a highly dynamic environment.
  • Data Standards: Experience and knowledge in the application of data standards.
  • Data Capture Systems: Familiar with data capture systems and databases (i.e., Medidata, Rave, Oracle OC/RDC, Oracle Inform).
  • Clinical Data Flow: Knowledge and understanding of clinical data flow, transfer, and integration.
  • Microsoft Office: Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint).
  • Clinical Data Repositories: Working knowledge of clinical data repositories is preferred.
  • Visualization Packages: Experience in working with visualization packages (i.e., Spotfire, Tableau) is a plus.

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