Leadership Bios

Nicole C. Close, PhD

President and Principal Biostatistician

Qualities: As founder, president, and principal biostatistician at EmpiriStat, Nicole is the driving force behind the company’s success. With an eternally optimistic outlook, a passion for hard work and detail, and a unique creativity and humor, Nicole inspires her team and clients alike to surpass expectations.

Role: Nicole serves as the senior biostatistician to EmpiriStat statisticians and statistical programmers. She provides guidance for regulatory submissions work, leadership for clinical development projects, and is directly responsible for the statistical integrity, adequacy, and accuracy of the clinical studies developed and produced by her colleagues.

Background:

• Trained in Epidemiology and Biostatistics (Juniata College, Case Western Reserve University and The George Washington University)
• More than 16 years of professional experience conducting and managing clinical trials and epidemiological research—including the management of coordinating centers and large-scale, multi-site data collection and statistical analysis activities
• Board Member, Committee Chair, and workshop faculty member for a variety of professional organizations including the American Statistical Association (ASA), The Society for Clinical Trials (SCT), and the International Society for Clinical Biostatistics (ISCB). She is a peer reviewer for several organizations including the Congressionally Directed Medical Research Program (CDMRP), the National Institutes of Health (NIH), and the Health Resources and Services Administration (HRSA), as well as training members and serving on various Data and Safety Monitoring Boards.
• Founded EmpiriStat in 2008

Devin J. Hunt

Manager, Statistical Programming

Qualities: Devin embodies the rare combination of out-of-the-box thinking with extraordinary left-brained organization. He has an unparalleled ability to structure data in a way that is crystal-clear yet also illuminates deeper, more meaningful information.

Role: As Manager of Statistical Programming, Devin provides SAS programming support for clinical trial data and provides technical knowledge for clinical trial design and implementation. He is also responsible for the overall management of other statistical programmers, data management personnel and activities and the function of the group as a whole.

Background:

• Trained at Juniata College for a B.S. degree and currently completing a Master’s degree at The George Washington University
• SAS Certified Base Programmer for SAS 9 with a wide range of experience in Pre-clinical to Phase III clinical trials
• Experience working for Contract Research Organizations (CROs), Sponsor organizations, private pharmaceutical companies and government agencies
• Expertise with Clinical Data Interchange Standards Consortium (CDISC) modules which are currently being implemented within the pharmaceutical and biotech industries

Caylee A. Ortega

Director of Business Development and Senior Contract Administrator

Qualities: Caylee is a true patriot who served in the U.S. Army. With her military background, Caylee is an energetic motivator and cheerleader for EmpiriStat, with passion and ethical integrity that inspires the whole team. Her attention to detail is perfectly balanced by her sense of humor.

Role: As Director of Business Development, Caylee leads and develops the company’s business development activities. She builds and manages client/market relationships with potential new clients and agencies to facilitate new client business growth. She also develops strategies, business plans and captures activities for future work consistent with overall company strategy.

As Contract Administrator, Caylee manages contract documents and all associated files. As a Defense Acquisition Professional, she possesses an in-depth understanding of federal contracting and acquisition. She assists with contract development, administration, tracking, and analysis—as well as communicates supplier performance and contract compliance. She reviews all contract modifications, extensions and contract closeout documents.

Background:

• U.S. Army Veteran
• Defense Acquisition Certified Program Manager with over 23 years experience in Department of Defense Activities including Business Development, Strategic Planning, Government Contracting, Defense Acquisition, and Program Management
• Managed the Business Operations of a multimillion dollar Medical Research Information Systems Program (MeRITS)
• Served as Program Manager of a Clinical Research Organization providing bench-to-bedside services to the Department of Defense for the Walter Reed Army Institute of Research (WRAIR), the WRAIR Clinical Trials Center, and the WRAIR Pilot Bioproduction Facility, managing over 200 employees

Chuck Wagner

Executive Coordinator; Business Development Coordinator

Qualities: If Nicole is the driving force behind EmpiriStat, Chuck is the company’s anchor. His perpetually upbeat, can-do attitude is infectious. He is always accessible, and will always finish a project (even without sleep) and keep everyone satisfied beyond expectations.

Role: As Executive Coordinator, Chuck uses his diverse and complex background in back-office operations to orchestrate day-to-day operational and administrative functions. He is also a valuable contributor on project-specific tasks. Another key aspect of Chuck’s role is managing a staff of Scientific Administrative Support Specialists.

In his role as Business Development Coordinator, Chuck Wagner assists the Director, Business Development in growing the company and driving new revenues with a focus on core deliverables such as increasing brand awareness, bringing in new customers, and coordinating public relations efforts. Mr. Wagner also provides pivotal input on the proposal teams and at times manages proposal writing efforts.

Background:

• Formerly Administrative Coordinator for a large research Registry sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Juvenile Diabetes Research Foundation International (JDRFI)
• Extensive experience in the preparation and formatting of clinical protocols, manuals of operations, Investigator Brochures, creation and design of Case Report Forms, managing and assisting data entry processes and preparation of blinded Data and Safety Monitoring Board materials and administration
  

Michael D. Hart

Quality Officer

Qualities: Mike guides the EmpiriStat team with the same patience, fairness, and (when necessary) stern approach that he exercises daily with his three boys, who are 10, 9, and 5! This combination of understanding and discipline makes him the kind of person everyone enjoys working with (even when he has to set them straight).

Role: As Quality Officer, Mike oversees the total set of characteristics of a product or service that affect its ability to satisfy a client’s stated or implied needs. He trains and instructs staff in this quality process implementing a culture within the group that quality is everyone’s responsibility. He strengthens this culture with the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

Background:

• Trained at Shippensburg University in Pennsylvania
• Spent his career focused in customer service
• Has worked with Accreditation bodies, auditing laboratories for accreditation, managing accreditation auditors and serving and managing Technical Advisory Committees.
• Has formal ISO/IEC training on ISO/IEC 17025, 6 years of experience assessing laboratory compliance to ISO/IEC 17025, review of laboratory corrective actions, training and guiding assessors in the assessment of laboratories to ISO/IEC 17025
• Served on professional international committees responsible for the development and maintenance of testing and quality standards, and has worked with government and private agencies in the development of specific quality and technical requirements for their contracted testing laboratories.