Associate Director, Biostatistics

Gaithersburg, MD 20697

Posted: 05/09/2019 Category: Pharmaceutical Job Number: 281691-1_1
Smith Hanley Associates
Associate Director, Biostatistics
Gaithersburg, MD
Nihar Parikh - [email protected]

In this role you will provide leadership on statistical methodology, study design, clinical development plans, and strategic insights. Seeking candidates with experience in Oncology, Cardiovascular, or Disease therapeutic areas.

Responsibilities:
Lead the clinical development process, formulation strategy, and regulatory guidance within a therapeutic area.
Provide statistical analysis and data interpretation for CSRs.
Oversee Statistical Analysis Plans and regulatory submissions.
Collaborate with cross-functional teams by driving statistical thinking, data analysis, and study protocol.
Provide statistical guidance and mentor statisticians.

Requirements:
Advanced Degree in Biostatistics, Statistics, or similar field and 6-8 years of experience in the pharmaceutical industry.
Experience with clinical study design, statistical methodology, and analysis.
Experience in regulatory interactions and submissions.
Knowledge of ICH/EMEA/FDA guidelines.
Experience managing projects, mentoring statisticians, and effective team leadership skills.

Smith Hanley Associates is a niche recruiting agency. #GD

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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