Associate Director, Biostatistics

Gaithersburg, MD 20697

Posted: 05/09/2019 Category: Pharmaceutical Job Number: 281644-4_1
Smith Hanley Associates
Associate Director, Biostatistics
Washington DC area
Nihar Parikh - [email protected]

In this role you will provide statistical leadership to support drug products within Oncology, CNS, Infectious Disease or similar therapeutic area. Guide statistical methodology, study design, clinical development plans, and analysis as well as reporting of deliverables.

Responsibilities:
-Lead statistical aspects of the clinical development process and regulatory strategy.
-Provide strategic input and ensure quality of deliverables meets standards.
-Oversee Statisticians and review statistical protocol, SAP's, and regulatory submissions.
-Responsible for CSR's, statistical methods, study design and interpreting results.
-Collaborate with Clinical Research teams and promote statistical thinking.

Qualifications:
-MS or PhD in Biostatistics, Mathematics, or related discipline.
-Experience in Pharma as well as Oncology, CNS, Infectious Disease or similar.
-Experience in statistical analysis plans, drug development, program design, interpretation and data analysis.
-Submissions and regulatory interaction experience.
-Experience with FDA guidelines, statistical protocol and team management.
-Proven leader and technical expert.

Smith Hanley is a niche recruiting agency. To view our jobs, please go to http://jobs.smithhanley.com/

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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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