Director/Sr Director, Biostatistics

Gaithersburg, MD 20697

Post Date: 08/02/2018 Job ID: 281176-10_1 Category: Pharmaceutical
Smith Hanley Associates
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.


Smith Hanley is a niche recruiting agency. To view our jobs, please go to

Nihar Parikh
Executive Recruiter

Nihar manages recruiting in biostatistics and other clinical areas. He likes recruiting because it allows him to impact a company’s greatest asset, their employees.  

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