OBJECTIVE
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.
EMPLOYMENT HISTORY
American Research Partners, LLC
Biostatistician and Regulatory Affairs Consultant 2010-Present
•
Statistical support for regulatory submissions and peer reviewed articles
Statistical support for regulatory submissions and peer reviewed articles•Regulatory strategy and submission consulting
Regulatory strategy and submission consulting•Protocol development
Protocol development•Process validation and improvement
Process validation and improvementDePuy, Inc. (Johnson & Johnson; orthopaedics)
Manager Biostatistics2006 – 2010
2006 – 2010•Supervise five professionals
Supervise five professionals•Responsible for statistical support of four PMA applications
Responsible for statistical support of four PMA applications•Responsibilities of Project Leader Biostatistics position
Responsibilities of Project Leader Biostatistics position•Extensive interaction with the FDA
Extensive interaction with the FDA•Supervise medical writers
Supervise medical writersProject Leader Biostatistics and Data Management 2004 – 2006
2004 – 2006•Responsible for developing a database that captures DePuy clinical outcomes
Responsible for developing a database that captures DePuy clinical outcomes•Spearhead effort to publish and present DePuy clinical results
Spearhead effort to publish and present DePuy clinical results•Statistical lead for computer aided surgery, hip and trauma products
Statistical lead for computer aided surgery, hip and trauma products•Provide statistical support to Product Development and Emerging Technologies groups
Provide statistical support to Product Development and Emerging Technologies groups•Assist in the design and analysis of international clinical studies
Assist in the design and analysis of international clinical studies•Supervisory responsibilities
Supervisory responsibilities•Responsibilities of Biostatistician III position
Responsibilities of Biostatistician III positionProject Leader Biostatistics and Outcomes Research2000 – 2004
2000 – 2004•Supervised up to four direct reports, including non-exempt and professional employees
Supervised up to four direct reports, including non-exempt and professional employees•Contributed to the development of methods designed to collect healthcare reimbursement data
Contributed to the development of methods designed to collect healthcare reimbursement data•Assisted in selecting and validating Oracle Clinical (part 11 compliant software)
Assisted in selecting and validating Oracle Clinical (part 11 compliant software)•Responsibilities of Biostatistician III position
Responsibilities of Biostatistician III positionBiostatistician III1999 – 2000
1999 – 2000•
•Analysis plans and protocols for IDEs and studies of commercial products
Analysis plans and protocols for IDEs and studies of commercial products •PMA and 510k statistical reports (primarily using SAS)
PMA and 510k statistical reports (primarily using SAS) •Provide statistical analysis, editorial assistance and write peer reviewed articles
Provide statistical analysis, editorial assistance and write peer reviewed articles•Interface with FDA and answer questions pertaining to submissions
Interface with FDA and answer questions pertaining to submissions•Software selection and evaluation
Software selection and evaluation•Provide statistical support for several drug/device and biologic products including the PROSTALAC hip (now commercially distributed).
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
Support Quality Assurance and R & D with respect to experimental design and statistical analysis requirementsAmerican Research Partners
Copyright © 2020 American Research Partners LLC
All Rights Reserved.
Carleton Southworth: Curriculum Vitae
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