GD Resources · 14 hours ago
Clinical Director of Data and Biostatistics in Acton, MA - Locals Required
Acton, MA
Full-time
Onsite
Director/Executive
$130/hr - $130/hr
8+ years expGD Resources is seeking a Clinical Director of Data and Biostatistics to lead data operations for their Clinical Affairs team focused on medical devices. This role involves overseeing clinical data systems, ensuring data integrity, and supporting regulatory compliance across clinical studies while also managing statistical analyses of clinical study data.
Information Technology & Services
Responsibilities
Lead the development and execution of data management strategies for clinical trials involving medical devices
Support the design of clinical studies and ensure accurate interpretation of clinical study data working cross functionally to ensure the needs of the business are met
Lead the development and execution of statistical analysis plans for clinical studies
Oversee the design and validation of clinical databases (e.g., EDC systems) and ensure alignment with study protocols and regulatory requirements
Collaborate with cross-functional teams including Clinical Operations, Medical Affairs, Regulatory Affairs, and Quality Assurance
Ensure high-quality data collection, cleaning, and reporting processes
Manage data management and biostatistics vendors and CROs, ensuring deliverables are met on time and within budget
Develop and maintain SOPs and best practices for biostatistics and data management activities
Provide leadership and mentorship to data management and biostatistics staff. This role will have direct reports
Performs other duties as required
Qualification
Required
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
Team player
Ability to organize and judge priorities
Excellent ability to generate and maintain accurate records
Company
GD Resources
GD Resources is a forward-thinking, Women Veteran-Owned firm specializing in Business Management, Information Technology, Professional and Staffing Services.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Joseph G.
Chief Operations Officer
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