Director of Data and Biostatistics

Advantage Technical
$148.00-$148.00
United States, Massachusetts, Acton
Dec 03, 2025
Ready to shape the data strategy behind innovative medical technologies? Join a forward-thinking clinical organization known for advancing patient health through rigorous research, high-quality data practices, and evidence-based decision-making. If you excel in leading data operations and statistical strategy, this high-impact role is your next step-apply now. About the Role The Director of Data and Biostatistics oversees all data management and statistical activities supporting clinical research for medical devices. This role leads the design, execution, and oversight of data systems, ensuring data integrity, regulatory compliance, and accurate statistical evaluations. You will guide clinical data processes from study design through analysis and reporting, while providing leadership to internal teams and external partners. Key Responsibilities Lead development and implementation of data management strategies for clinical trials. Support clinical study design and ensure accurate interpretation of clinical data. Develop and oversee statistical analysis plans and ensure appropriate methodologies. Lead design, validation, and oversight of clinical databases (EDC systems) aligned with protocols and regulatory requirements. Collaborate with Clinical Operations, Medical Affairs, Regulatory Affairs, Quality, and other partners. Ensure high-quality data collection, cleaning, and reporting workflows. Manage CROs and external vendors for data and biostatistics deliverables. Develop and maintain SOPs and best practices. Provide leadership, mentorship, and direct supervision to data and biostatistics staff. Qualifications Master's degree in Life Sciences, Health Informatics, Biostatistics, or related field. 8-10 years of clinical data management and/or biostatistics experience; 3+ years in leadership. Experience in medical device clinical trials and strong understanding of FDA/ISO regulations. Proficiency with EDC systems (e.g., Rave, InForm, REDCap). Knowledge of statistical methods, CDISC standards, and data quality processes. Strong communication, leadership, and project management skills. Ability to work onsite as needed in Acton, MA. Apply today and bring your expertise to an organization where data drives meaningful impact. After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play. About Us Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies. Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.