Biostatistics/Regulatory Affairs/Clinical Research Management Consulting contract where experience in all phases and aspects of Clinical Research will contribute to the commercial success of medical products.


American Research Partners, LLC

Biostatistician and Regulatory Affairs Consultant  2010-Present

Statistical support for regulatory submissions and peer reviewed articles
Regulatory strategy and submission consulting
Protocol development
Process validation and improvement

DePuy, Inc. (Johnson & Johnson; orthopaedics)

Manager Biostatistics2006 – 2010

Supervise five professionals
Responsible for statistical support of four PMA applications
Responsibilities of Project Leader Biostatistics position
Extensive interaction with the FDA
Supervise medical writers

Project Leader Biostatistics and Data Management 2004 – 2006

Responsible for developing a database that captures DePuy clinical outcomes
Spearhead effort to publish and present DePuy clinical results
Statistical lead for computer aided surgery, hip and trauma products
Provide statistical support to Product Development and Emerging Technologies groups
Assist in the design and analysis of international clinical studies
Supervisory responsibilities
Responsibilities of Biostatistician III position

Project Leader Biostatistics and Outcomes Research2000 – 2004

Supervised up to four direct reports, including non-exempt and professional employees
Contributed to the development of methods designed to collect healthcare reimbursement data
Assisted in selecting and validating Oracle Clinical (part 11 compliant software)
Responsibilities of Biostatistician III position

Biostatistician III1999 – 2000

Analysis plans and protocols for IDEs and studies of commercial products 
PMA and 510k statistical reports (primarily using SAS)  
Provide statistical analysis, editorial assistance and write peer reviewed articles
Interface with FDA and answer questions pertaining to submissions
Software selection and evaluation
Provide statistical support for several drug/device and biologic products including the PROSTALAC              hip (now commercially distributed).
Support Quality Assurance and R & D with respect to experimental design and statistical analysis              requirements

American  Research Partners
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Carleton Southworth: Curriculum Vitae

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