Director of Data Management

4 weeks ago


Massachusetts, United States EPM Scientific Full time

This person will be responsible for the hands on work at a program/study level in addition to leading/managing a small team of statisticians. The team is looking for someone with strong regulatory submission experience as this role involves close collaboration with key stakeholders to support decision-making, communication, and regulatory submissions.

Collaborate with stakeholders to provide timely, high-quality statistical support to clinical programs.
Supervise project team members, ensuring scientific rigor and cross-functional collaboration.
Participate in vendor selection, process improvement, and enhancing statistical expertise.
Ensure compliance with regulatory guidelines and company SOPs.
Be accountable for statistical activities in regulatory submissions.
Author relevant sections of regulatory documents and address comments.
Provide statistical inputs in study-level documents and clinical development programs.
Develop statistical analysis plans and oversee data management.
Collaborate on data algorithms, reports, and visualizations for data quality and insights.
Oversee vendors providing statistical, programming, and data management services.

PhD in Biostatistics
~Strong People Management Experience



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