Associate Director/ Director Biostatistics--Clinical - (US-CA-San Francisco)

Minimum Education: Doctorate
Job Type: Full Time
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My Public San Francisco Biotech Company is engaged in the development, of therapeutics for the treatment of cancer.

Associate Director/ Director Biostatistics--Clinical

Overview:

Leads the biostatistics function and personnel to develop and execute statistical strategy, design and analyses for clinical trials in all phases that establish the conditions essential for determining dose, safety, efficacy, and marketability of pharmaceutical and/or biological products. Applies sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements. Develops and/or applies statistical theories, methods and software. Partners in program design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data. Recruits, develops, and supervises project statisticians. Develops and implements biostatistics department policies, standards, practices and work-instructions in coordination with leaders in other functions. Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success. Represents biostatistics function in interactions with institutional review boards, ethics committees, and health agencies. Manages timelines, deliverables and budgets of contract research organizations.

Requirements:

Five to ten years of experience as a biostatistician supporting clinical trials, preferably in the therapeutic area of oncology and in the biotech/pharmaceutical industry
-Management and statistical analysis of data obtained from Phase I – III clinical studies in support of US NDAs.
-Supervision of multiple senior-level statisticians preferred
-Direct experience with FDA/EU Authority preferred

Michael A. Terretti
Managing Director
Global Life Sciences
MRI-Raleigh
919-781-0400x112 office
mterretti@mriraleigh.com

Michael A. Terretti
Mike Terretti
5171 Glenwood Ave Suite 350
Raleigh, NC 27612
Phone: 919-781-0400x112

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Mr. Terretti’s focus is the Pharmaceutical and Biotechnology Industries. He also works in selected segments of Information Technology (ERP, Bioinformatics, HPC), Private Equity/Venture Capital & Healthcare.

He has over 24 years of Domestic and International General Management, Manufacturing, R&D, Marketing and Sales Management in Clinical Diagnostics, Toxicology, Biomedical Instrumentation, Biotechnology, Environmental Testing, Genetic Testing and Drug Testing markets with P&L responsibility.

His executive management background in the above focused industries provides you the seasoned experience and knowledge of understanding your needs and business. His breadth of experience permits him to analyze the course of action, which will best maximize and facilitate his client’s objectives. His successful record as an Executive Recruiter demonstrates his ability to be analytical, tenacious and a consistent achiever of his client’s goals.

Mr. Terretti has a formal Biomedical/Technical background (Chemistry and Immunology) integrated with extensive Biotech/Healthcare business experience. This is the winning formula that his client’s find invaluable in Business and Technical Searches.

Management Recruiters of Raleigh (MRI Raleigh), a woman owned business, is an executive search-recruiting firm located in Raleigh, NC near the Research Triangle Park. We are ranked in the top 2% of more than 1100 offices aligned with Management Recruiters International, Inc. headquartered in Philadelphia, PA. With over 1100 offices operating in over 35 countries around the world, we have one of the world’s largest talent pools. By combining our size and scope with an IT infrastructure enabling real-time access to candidates, information and training, Mr. Terretti is the Managing Director of the Global Life Sciences Group at MRI-Raleigh.

Mr. Terretti was #1 in the Raleigh office for Life Sciences for 2007 and in the top one half per cent of all 5000 MRI Executive Recruiters worldwide.

Of 10,000+ companies in our industry, MRII is currently the #1 executive search organization in the country. The Raleigh office was founded in 1976, our firm specializes in managerial, technical, logistics, sales and marketing staffing needs for manufacturing, engineering, pharmaceutical and healthcare corporations nationwide and internationally.

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