Director Of Biostatistics
Job in
Waltham, Middlesex County, Massachusetts, 02453, USA
Listed on 2026-10-16
Listing for:
Green Key Resources
Full Time
position Listed on 2026-10-16
Job specializations:
-
Engineering
Regulatory Compliance Specialist, Data Science Manager, Research Scientist
Job Description & How to Apply Below
Employment Full Time Working Type Hybrid Job Reference Salary Type Annually Industry Pharmaceuticals Selling Points Lead impactful statistical strategies for rare disease projects in a dynamic environment. Collaborate with cross-functional teams and regulatory agencies to drive innovation. Mentor teams while contributing to industry advancements.
Job Description Overview Lead statistical strategy and provide scientific guidance for rare disease and blood disorder projects.
Collaborate with cross-functional teams to influence development plans and submissions.
Represent statistical expertise in regulatory meetings and external interactions.
Mentor and develop team members, fostering a culture of innovation and collaboration.
Ensure compliance with SOPs, standards, and regulatory expectations.
Optimize resource allocation and oversee external partner collaborations.
Contribute to process optimization and continuous improvement initiatives.
Provide technical leadership and influence cross-functional decision-making.
Key Responsibilities & Duties Lead statistical aspects of clinical development plans, study designs, and analyses.
Drive statistical strategy across development programs and influence project decisions.
Mentor statisticians and team members, promoting collaboration and operational excellence.
Ensure project compliance with standards and regulatory expectations.
Plan, track, and oversee project activities, timelines, and resource allocation.
Represent statistics in regulatory meetings and scientific collaborations.
Contribute to the development and refinement of statistical standards and practices.
Collaborate with external partners to ensure quality and timely delivery.
Job Requirements
PhD in Statistics or related field, or MS with 10 years of experience.
8+ years of pharmaceutical industry experience in clinical development.
Strong knowledge of advanced statistical concepts and methodology.
Proven leadership in complex project or program support.
Experience with regulatory submissions and external stakeholder interactions.
Ability to influence cross-functional teams and senior leadership effectively.
Broad experience in clinical development and post-marketing activities.
Commitment to fostering collaboration and operational excellence.
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