The ARA Team
Advance Research Associates has employees with the qualifications that you need for your clinical trial. Let’s take a look at our management team profiles:
Peter Shabe
Founder and President
Peter has over 25 years of experience in Phase I-IV clinical trials of drug and medical device development. He has hands-on experience in clinical trials data, from data collection, database design, and data entry through data quality assurance and data analysis. His expertise includes using SAS for developing data management and data analysis applications, as well as analyzing and reporting clinical data. Peter began his career at Syntex, and held positions as Senior Statistician at Cetus and Collagen. He served as Associate Director of Database Services and Statistical Programming at PAREXEL, as well as Director of Biostatistics and Project Management at Resource Biometrics. Peter received his M.S. in Statistics from Marquette University and he currently teaches courses at San Francisco State University, at San Jose State University and at University of California Santa Cruz.
Annie Hung
Senior Director, Biostatistics
As ARA’s Director of Biostatistics, Annie Hung draws on over 15 years of experience in all phases of drug development in the pharmaceutical and biotechnology industries. Her therapeutic areas of experience include Phase I, II, and III in oncology and infectious therapeutic areas, as well as respiratory, pain, dental implant, and endocrine therapeutic areas.
Ms. Hung’s experience with the management of clinical trials data extends from data collection, database design, and data entry through data quality assurance and data analysis. She has participated in setting up and supporting Data Safety Monitoring Boards for Pharmaceutical products, and has extensive experience in using SAS for analyzing and reporting clinical data and for developing data management and data analysis applications.
Currently, Annie Hung manages statistics and statistical programming at ARA. She ensures scientific integrity in the application of statistical methodology to clinical trials, provides statistical direction and technical oversight for projects, and represents clients at FDA meetings or other scientific meetings as required.
Ms. Hung holds an M.A. from the University of Michigan, Ann Arbor, and was a Pre-Candidate, Ph.D. Program – Statistics at the University of Michigan, Ann Arbor. She continues her professional development by attending conferences and seminars each year, including continuing education courses and workshops.
Michelle Stoddard
Senior Director, Operations
As ARA’s Director of Operations, Michelle Stoddard is responsible for planning and implementing business development strategies for ARA in conjunction with the ARA President, organizing strategies for compliance with 21 CFR Part 11, CDISC and other regulations, guidance, or industry standards relevant to ARA, and serving as project manager on a variety of projects and with multiple clients.
She has over 17 years of Clinical Data Management and Clinical Research experience in the Medical/Hospital and Biotechnology/Pharmaceutical Industry fields, as well as 10 years of Project Management, Data Management, and Clinical Research.
Using her extensive knowledge of the structure and functionality of clinical databases and her understanding of clinical data and its translation into a meaningful database, Ms. Stoddard is able to successfully coordinate communication and completion of tasks between ARA and multiple clients. She works with clients to establish project timelines and tasks, disseminates tasks and assigns priorities to all members of the project team, and ensures client deliverables are met related to the scope of work.
Ms. Stoddard holds a B.S. in Physiology from the University of CA, Davis, and is a member of the Society for Clinical Data Management.
Jeffrey Sadik
Associate Director, Data Management
As ARA’s Associate Director of Data Management, Jeffrey Sadik is responsible for ARA’s day-to-day data management operations. In addition to interfacing with clients on project timelines and deliverables and reviewing and evaluating Data Management Plans and other project-related documents for adherence to protocol and accuracy, Mr. Sadik ensures that deliverables are accurately identified and meet all internally and externally defined quality standards. Mr. Sadik assists ARA’s CEO with developing, implementing and monitoring strategies that meet the goals of the company.
Mr. Sadik has fifteen years of clinical research experience, actively managing people, Phase I-IV studies, 510k and PMA-related studies, and building lasting relationships within and across organizations. He has work experience within medical device, biotech, CROs and pharmaceutical businesses. He drove departmental initiatives using SDLC methodology to develop, validate, and implement new EDC installations and supporting applications.
Mr. Sadik holds a B.S. with honors from the University of Phoenix, Bellevue, Washington, with a major in Information Technology. He is a Drug Information Association (DIA) member, and, for the Society for Clinical Data Management (SCDM), served as a prior annual conference session chair and presenter on EDC, and as a prior committee chair.
Heather Zollinger
Senior Quality Systems Manager
Heather has 12 years of experience in document management and technical writing in the fields of Clinical Trials, Finance, and hardware and software development. For the past 7 years she has documented and managed process controls, internal compliance, and audits in fields regulated by either the FDA or SEC, and now serves as the Quality Systems Manager for Advance Research Associates, Inc., where she is responsible for the implementation and oversight of all aspects of ARA’s Quality Management System.
Heather graduated magna cum laude from the University of Colorado, Boulder with majors in Environmental Studies and English. She continues her professional development with courses specific to Good Clinical Practice, Quality Systems Management, and Internal Auditing.
