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Sr. Clinical Data Analyst

Company: Endologix
Location: Irvine
Posted on: March 13, 2023

Job Description:

Utilize personal experience and technical expertise to provide support of the Clinical Analytics team as we analyze, interpret, and present both clinical and non-clinical data to stakeholders. -Plan and lead the development of statistical programming solutions to the Analytics team. -

  • Initiate, plan, execute and manage all aspects of data analysis/management such as case report form design, define/program database/edit check specifications, assist in mid-study updates (MSU) contribute to the creation and maintenance of databases
  • Analyze clinical datasets within the SAS suite and present results in a comprehensive and intuitive fashion to regulatory, clinical, and marketing audiences. - Provide deliverables with an emphasis on quality and clarity for all regulatory submissions
  • Support junior-level SAS programmers and cross-functional efforts of SAS programmers working with complaint data
  • Collaborate with R&D team for analysis and design of experiments for stent design and tolerances, polymer chemistry formulation and performance
  • Collaborate with Quality team for analysis of QC/Complaint trends, and support the development of automation of these tasks
  • Collaborates with database developers on the design, documentation, testing and implementation of study database based on data management and protocol requirements. -
  • Develops reports to track study progress to help the study team ensure timelines and quality expectations are met
  • Identify risks & mitigation actions for data management related deliverables -
  • Maintain a broad understanding of current processes and methods as well as trends and directions of clinical data management and data analysis fields
  • Reviews Statistical Analysis Plans (SAPs) and develops SAS solutions for timely presentation of corresponding tables/listings/graphs
  • Assist in the calculation of sample sizes for new studies and selection of appropriate statistical approach

    • Integrate databases from multiple studies or sources. Support summarization and transfer of databases to internal and external sources
    • Assists in data cleaning processes
    • Assist in validation of statistical suites (SAS) and statistical codes in accordance with regulatory standards and validation procedures
    • Develops and maintains good communications and working relationships with teams
    • Understands and complies with Standard Operating Procedures and Work Instructions. -Assists in developing, revising, and maintaining data management standards, Operating Procedures and Work Instructions

      • Define and understands the data review requirements and processes to ensure delivery of the highest quality of data and the analyses based on this data -

        • Performs other duties as directed by clinical analytics management -


          • (To perform the job successfully, an individual should demonstrate the following competencies):

            • Past experience in multiple clinical databases
            • SAS 9 (SAS/BASE, SAS/GRAPH, SAS/STAT, SAS/ODS), MS Office
            • Broad exposure to Data types and database structures and query languages
            • Ability to comprehend study specific requirements
            • Able to work in a matrix/shared resource environment
            • Cope with constant requests for tables/charts/reports and any changes to such existing requests from study team
            • Experience in training junior-level analysts to support projects
            • Manage projects with little supervision

              Minimum Education: Bachelor's degree in natural sciences field with training in Biostatistics and SAS or other statistical language suites
              Minimum Experience: A minimum of 4 years of working experience with hands on data management, statistical analysis, or statistical software suite such as SAS or R. Past work experience in a related regulated industry is a plus

Keywords: Endologix, Irvine , Sr. Clinical Data Analyst, Healthcare , Irvine, California

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