Associate Director, Biostatistics

Morris County, NJ 07054

Post Date: 06/12/2018 Job ID: 281295-2_1 Category: Pharmaceutical
Smith Hanley Associates
Associate Director, Biostatistics
Morris County, NJ
Nihar Parikh, [email protected]

Oversee statistical aspects of clinical studies and submissions, collaborate with clinical and regulatory leads, create clinical plans, and develop statistical approaches.

Responsibilities:
-Execute statistical analysis, clinical study reports, and provide clinical and regulatory guidance
-Manage direct reports, clinical development plans, and statistical deliverables
-Implement technical data standards and data collection as well as work with cross functional teams
-Adhere to regulatory requirements, department guidelines, and compliance procedures
-SAS programming, data models, and data package submissions

Qualifications:
-MS/PhD and 5+ years experience in the pharmaceutical/biotech industry required
-Experience in statistical methodology, clinical research, drug development and regulatory guidance
-Experience in SAS programming, clinical trial methodologies, strategic plans, and clinical study design
-Experience in Neuroscience or Pain therapeutic areas and clinical trials
-Experience in drug submissions, life cycle management, and advanced statistical concepts
-Previous management experience

www.smithhanley.com

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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