Job Description

Job Title: Clinical Director of Data and Biostatistics
Job Location: 12 Months


Must be local to Acton, MA and available for onsite meetings



Description:
The Director of Data and Biostatistics will lead data operations for our Clinical Affairs team focused on medical devices. This role will be responsible for overseeing the design, implementation, and maintenance of clinical data systems, ensuring data integrity, and supporting regulatory compliance across all clinical studies. In addition, this role will be responsible for overseeing the statistical analysis of clinical study data ensuring appropriate statistical methods and accurate analyses to evaluate efficacy and safety and answer research related questions.



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.

• 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.

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