Gardner Resources Consulting, LLC
Director of Data and Biostatistics
Gardner Resources Consulting, LLC, Lexington, Massachusetts, United States, 02173
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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.
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.
Ability to organize and judge priorities.
Excellent ability to generate and maintain accurate records.
Seniority level Not Applicable
Employment type Contract
Job function
Management
Pharmaceutical Manufacturing
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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.
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.
Ability to organize and judge priorities.
Excellent ability to generate and maintain accurate records.
Seniority level Not Applicable
Employment type Contract
Job function
Management
Pharmaceutical Manufacturing
#J-18808-Ljbffr