Director/Sr Director, Biostatistics
Gaithersburg, MD 20697
Director/Senior Director, Biostatistics - Oncology
Washington DC area
Nihar Parikh - [email protected]
In this role you will lead clinical development plans, regulatory submissions, and strategy for various drug products.
-Manage a group of 5-10 statisticians within the Oncology team on program design, clinical product development, and strategic initiatives.
-Statistical work standardization within product compliance.
-Oversee CRO and other partners on deliverables and quality standards.
-Implement statistical approaches for value demonstration and regulatory guidance.
-Provide leadership across projects and implement best practices to deliver innovative solutions.
-Maintain relationships with collaborative groups, consultants, and organization leaders.
-MS or PhD in Biostatistics, Mathematics, or related discipline.
-Experience in Pharma and Oncology required.
-10+ years of experience in statistical analysis, drug development, program design, interpretation and data analysis.
-Submissions and regulatory interaction experience.
-Proven leader, must have experience managing teams.
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