Advantage Technical
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.
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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.
#J-18808-Ljbffr