Director of Data and Biostatistics

Director of Data and Biostatistics

Location: Massachusetts (must be local for in-person meetings)

Compensation: Up to $148/hour

Position Overview

The Director of Data and Biostatistics will lead data operations for the Clinical Affairs team focused on medical devices. This role is responsible for overseeing the design, implementation, and maintenance of clinical data systems, ensuring data integrity, and supporting regulatory compliance across all clinical studies. Additionally, the Director will oversee statistical analysis of clinical study data, ensuring appropriate methods and accurate evaluations of efficacy and safety to address research questions.

Key Responsibilities

• Lead the development and execution of data management strategies for medical device clinical trials.
• Support the design of clinical studies and ensure accurate interpretation of study data, working cross-functionally to meet business needs.
• Develop and execute statistical analysis plans for clinical studies.
• Oversee the design and validation of clinical databases (e.g., EDC systems) to ensure alignment with study protocols and regulatory requirements.
• Collaborate with Clinical Operations, Medical Affairs, Regulatory Affairs, and Quality Assurance teams.
• 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.
• Provide leadership and mentorship to data management and biostatistics staff (direct reports).
• Perform other duties as required.

Education & Experience

• Master’s degree in Life Sciences, Health Informatics, Biostatistics, or related field.
• 8–10 years of experience in data management and/or biostatistics within clinical research.
• Minimum 3 years in a leadership role.
• Strong background in medical device clinical trials with knowledge of FDA and ISO regulations (e.g., 21 CFR Part 11, ISO 14155).
• Proficiency with statistical methods.
• Experience with clinical data systems (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

• Strong written and verbal communication skills.
• Ability to collaborate cross-functionally across the organization.
• Proficiency in word processing, spreadsheets, databases, and internet research.
• Flexible and adaptable in a fast-paced environment.
• Team-oriented with strong organizational and prioritization skills.
• Excellent record-keeping and documentation accuracy.