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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