Biostatistics Lead

Gaithersburg, MD 20878

Posted: 11/08/2018 Category: Pharmaceutical Job Number: 280965-12_1
Smith Hanley Associates
Biostatistics Lead
Gaithersburg, MD
Nihar Parikh, [email protected]

Responsibilities:
-Indication lead and global submissions, statistical contributions to design
-Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation.
-Oversee Partners/CRO on Deliverables and Quality Standards
-Apply statistical approaches for value demonstration and regulatory guidance
-Global relationship development with collaborative groups, consultants, and international opinion leaders
-Statistical staff technical mentoring/coaching and educational support

Qualifications:
-PhD/MS in Biostatistics, Mathematics, etc.
-Experience in Healthcare/Pharma and Oncology, Respiratory, Cardiovascular, Diabetes or similar therapeutic area
-Experience in statistical expertise to complex problems; extensive Regulatory and technical knowledge
-Experience in Development, Program Design, Interpretation and Data Analysis
-Submissions and regulatory interaction experience
-Proven leadership experience

www.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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