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.