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A Qualified Team You Can Count On

Our Leaders

Pete Shabe | Founder & President | Advance Research Associates
Founder & President

Pete Shabe

Peter Shabe, the founder and President of Advance Research Associates, Inc. (ARA), has developed the company as one of the preeminent providers of data management, biostatistics, and statistical programming services to the pharmaceutical, biotech, medical device, and medical diagnostic industries. Peter is responsible for the business management and financial performance of the company.

Based on his many years of experience working as the principal biostatistician at sponsor companies and with ARA’s clients, Peter also provides statistical study design, clinical program strategic planning, and statistical input at meetings with regulatory agencies. Prior to founding ARA in 1996, he held positions of increasing responsibility in the biostatistics departments at various CROs and pharmaceutical companies including PAREXEL, Collagen Corporation, and Syntex. Peter enjoys teaching biostatistics to non-statisticians in the clinical trials programs at San Francisco State University and at University of California – Santa Cruz. Outside of work, Pete enjoys spending time with family and friends, listening to all types of music, and playing with his dogs.

Michelle Stoddard | Senior Director, Clinical Data Management | Advance Research Associates
Senior Director, Clinical Data Management

Michelle Stoddard

Michelle 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, evaluating and managing vendor relationships and serving as project manager on a variety of projects and with multiple clients.

She has over 25 years of Clinical Data Management and Clinical Research experience in the Biotechnology/Pharmaceutical/Diagnostic and Medical Device Industry fields, as well as 19 years of Project Management experience.

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.

Michelle holds a B.S. in Physiology from the University of CA, Davis. Outside of work, Michelle spends her time playing outside with every available chance.

Jennifer Nezzer | Senior Director, Biostatistics | Advance Research Associates
Senior Director, Biostatistics

Jennifer Nezzer

Jennifer Nezzer is the Sr. Director of Biostatistics at Advance Research Associates (ARA), located in Santa Clara, California. Home based in Austin, TX, as the head of the biostatistics and programming departments, she is responsible for the recruitment and management of team members, for providing technical leadership on the all aspects of numerous development projects in North America as well as providing consulting services to clients and serving as lead statistician on global programs. Prior to joining ARA, she was Director of Biometrics at Lotus Clinical Research, where she established the Biostatistics department, managed the Biostatistics and Data Management departments, leading the teams during the early adoption of the Veeva EDC platform. Prior to that. Jennifer was a member of the biostatistics leadership team at Premier Research and supported the biostatistical development of numerous global programs at Premier and PPD for more than 10 years.

Jennifer has supervised the statistical aspects of Phase I through IV clinical trials from design through analysis and reporting for both traditional and adaptive study designs in a broad range of therapeutic areas including analgesia, oncology, endocrine/metabolic, infectious/parasitic diseases, CNS, genitourinary, hematology, diseases of the musculoskeletal system and connective tissue, congenital anomalies and mental disorders. She has participated in multiple NDA submissions to FDA including developing ISS/ISE and eCTD submission ready documents.

Jennifer has represented biostatistics in interactions with sponsor companies, in multiple NDA submissions and represented multiple sponsors in both phone and face to face interactions with both US and exUS regulatory agencies.

Prior to her tenure in the pharmaceutical industry, Jennifer served as a senior biostatistician for Signature Science, LLC for eight years providing statistical support for various quality assurance, field testing and environmental projects. She earned her BA in statistics from Kansas State University, and her MS in statistics from New Mexico State University. She is a member of the American Statistical Association, Phi Beta Kappa and Phi Kappa Phi.

Andria Wallace | Quality Systems Manager | Advance Research Associates
SR. Quality Systems Manager

Andria Wallace

Andria is responsible for managing ARA’s Quality Management System, encompassing accountability and compliance with the industry requirements of ARA’s document management system, corrective and preventive action (CAPA) system, training, audits, and other regulatory requirements. As the ARA Data Protection Officer, she implemented and oversees the General Data Protection Regulation (GDPR) and California Consumer Privacy Act (CCPA) compliance obligations.

Andria has a master’s degree in Product Engineering and has a certificate in Clinical Trial Essentials from UC Santa Cruz. For the past 28 years she has worked in the areas of Quality Assurance, Project Management, and R&D for ARA, HP, and Microsoft. In her spare time Andria likes to travel, build things, and hike the Boise foothills with her dog Syd.

Our Experts

Yeni Nieves-Malloure | Project Director | Advance Research Associates
ASSOCIATE DIRECTOR OF BIOSTATISTICS

Yeni Nieves-Malloure

Yeni Nieves-Malloure is responsible for providing strategic and technical leadership on all aspects of various projects, managing and overseeing the Biostatistics team, and providing consulting services to clients. She is responsible for implementing and overseeing integration strategies between the biostatistics and programming operations with other operational groups at ARA and developing and implementing strategies that meet ARA’s goals.

Before joining ARA, Yeni was the Director of Global Biomedical Operations within 3M Healthcare Business Group, providing statistical expertise and strategic leadership to support clinical trials, regulatory submissions, and post-market activities across several product portfolios. She was responsible for the development, operation, and strategies for the Biostatistics, Statistical Programming, Data Management, and Medical Writing teams. Prior to that, Yeni managed the Biostatistics and Statistical Programming teams at KCI as a Senior Manager, served on the biostatistics leadership team, and as a lead Statistician at Premier Research and INC Research.

Yeni has experience contributing to the statistical aspects of Phase I through IV clinical trials from design through analysis and reporting for both traditional and adaptive study designs in therapeutic areas, including analgesia, oncology, nephrology, hematology, dermatology mental disorders, and medical device. She has participated in successful NDA submissions and obtaining De Novo Classification status.

Yeni has a B.S. in Applied Statistics from Purdue University, an M.S. in Biostatistics from Grand Valley State University, and currently pursuing an Executive MBA at Texas A&M University.

Carole Matthews | Senior Manager, Programming & Data Standards | Advance Research Associates
Senior Manager, Programming & Data Standards

Carol Matthews

As the head of ARA’s Programming team, Carol is responsible for planning and implementing process improvements that utilize SAS, SAS macros and other available technologies to maximize the efficiently of all programmers. She works across departments to determine where programmers can help increase overall project team efficiency, from generating complex database edit check listings to generating table output that is “drop-in ready” for medical writers. In these roles, she ensures that programming project timelines are met, performs project-related programming with an emphasis on figures, ad-hoc and project management-related tasks, mentors less experienced programmers, and provides input on programming time and resource estimates.

Carol has over 20 years of SAS programming experience in the pharmaceutical industry, working on the earliest phase clinical trials through leading large project teams working on complex US and EU submissions, three of which led to regulatory approvals. In addition to her extensive clinical trial experience, Carol spent over 5 years leading a team that focused on support for Risk Evaluation and Mitigation Strategy (REMS) tasks, including Knowledge, Attitude, and Behavior (KAB) surveys.

In addition to her work at ARA, Carol has been an adjunct faculty member in Thomas Jefferson University’s SAS Programming certification program since 1998, is actively involved with the annual PharmaSUG conference, and co-authored the book Validating Clinical Trials Data Reporting with SAS®, one of the first books on how to use SAS effectively for clinical trials programming.

Carol holds a B.A. in Psychology from The College of New Jersey. Outside of work, Carol enjoys riding her horses, fussing her cats, making jewelry, and traveling with her husband.

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