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Director of Data and Biostatistics
Director of Data and BiostatisticsGardner Resources Consulting, LLC • Lexington, MA, US
Director of Data and Biostatistics

Director of Data and Biostatistics

Gardner Resources Consulting, LLC • Lexington, MA, US
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Director of Data and Biostatistics

Education and Experience :

  • Master's degree in Life Sciences, Health Informatics, Biostatistics or related field.
  • Minimum of 8–10 years of data management and / or biostatistics experience in clinical research, with at least 3 years in a leadership role.
  • Strong background in medical device clinical trials and understanding of FDA and ISO regulations (e.g., 21 CFR Part 11, ISO 14155).
  • Knowledgeable in statistical methods.
  • Proficiency with clinical data systems (e.g., Medidata Rave, Oracle InForm, REDCap).
  • Experience with device data integration and analysis.
  • Solid understanding of database design, data standards (e.g., CDISC), and data quality assurance.
  • Excellent communication, leadership, and project management skills.

Skills / Competencies :

  • Excellent written and effective verbal communication skills.
  • Ability to communicate cross-functionally across the organization.
  • PC skills; word processing, spreadsheet, database, Internet search and utilization.
  • Flexible and able to work in a fast-paced environment.
  • Team player.
  • Ability to organize and judge priorities.
  • Excellent ability to generate and maintain accurate records.
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    Director Of Data • Lexington, MA, US

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