George E. DeMuth, M.S.

Mr. DeMuth first founded Stat-Tech Services, LLC, in 1996 in response to local industries' growing demand for independent biostatistics analysis and evaluation. For the past 22 years, he has worked as a statistician in a number of therapeutic areas and most specifically in support of pharmaceutical, biologic and medical device clinical research trials. His areas of expertise include, but are not limited to:

• Pre-market and post-surveillance clinical development plan and trial design
• CRF evaluation
• Sample size estimation
• Statistical analysis plan creation and review
• Development of figures, tables and listings for report writing
• Report writing
• FDA panel presentations
• Medical device submissions

Mr. DeMuth provides direct entrepreneurial leadership for the company and expert statistical consulting to his clients. He has proven experience in Bayesian analyses and adaptive designs and in tailoring SAS programming solutions to specific clients' needs. Mr. DeMuth has authored the Web Management System, co-authored the Macro Reporting System ("Building Systems of Macros: The Print System and The Macro Reporting System") and developed the shareware program, "The Stat-Companion".
 
Prior to founding Stat-Tech Services, Mr. DeMuth managed the biostatistics group at BRI International (acquired by Quintiles in 1996) and was a statistician with Burroughs-Wellcome Company, where he was awarded the Burroughs Wellcome Achievement Award in 1989 and the Burroughs Wellcome Excellence Award in 1994.
 
He earned his B.S. degree in Mathematics from the University of Michigan and his M.S. degree in Statistics from the University of North Carolina at Chapel Hill.

Martha R. Fuquay, M.S.

Ms. Fuquay co-founded Stat-Tech Services, LLC, in 1996 with George DeMuth. She has over 20 years of combined experience in healthcare and in business and operational management. She works closely with clients to anticipate and meet their needs in the areas of project strategy, data management, SAS programming and statistical packages. Her experience developing service agreements with existing clients' legal and contract departments has proven invaluable to new clients seeking to initiate a relationship with this specialty CRO.
 
Ms. Fuquay is responsible for overseeing the company's operational advancement and business expansion. In addition to being one of the company co-founders, she works closely with other members of the management team to identify growth opportunities and to ensure client expectations are being met. She ensures that each member of the company is responsible for owning and meeting both internal and external quality requirements.
 
Prior to co-founding Stat-Tech Services, Ms. Fuquay actively worked within the healthcare industry. She is trained in public health, specifically focused on the areas of physical and mental disabilities, rehabilitation, medical terminology and case management.
 
Ms. Fuquay earned her undergraduate degree in Psychology from Elon College and an M.S. in Rehabilitation Psychology and Counseling from the University of North Carolina at Chapel Hill.

Jeff Welch, B.A.

Mr. Welch has more than 20 years experience as an entrepreneur and senior executive in the healthcare and technology sectors. He has worked with and assisted numerous start ups and Fortune 500 companies in developing and executing strategic plans to foster stable and continuous growth.
 
Mr. Welch is responsible for new business development, client retention, creating strategic partnerships, brand building and corporate communication activities.
 
Prior to joining Stat-Tech Services, Mr. Welch was co-founder and managing partner to ActiveInsights, a marketing information services provider and an industry focused marketing consultant to the Biotech and Medical device sectors for the Triangle Business Journal.
 
He received a B.A. in Psychology from Boston University.

John R. Iwaniszek, M.S.

Mr. Iwaniszek has over 15 years SAS programming, macro development, and clinical trial experience. He has worked on a variety of pharmaceutical and medical device studies as well as developed programming strategies for complicated output.
 
As co-developer of the Macro Reporting System, Mr. Iwaniszek has extensive knowledge of the main SAS programming tools used by Stat-Tech Services. Mr. Iwaniszek is also knowledgeable about CDISC and ADAM standards. He has developed numerous programs to handle conversions to CDISC format and for Integrated Safety Summary Packages (ISS).
 
Mr. Iwaniszek has contributed to various SAS meeting presentations and was a company contributor to best poster at the 2008 and 2010 PharmaSUG meetings.
 
He earned a B.A. in Education from Berea College and an M.S. in Industrial Psychology from Springfield College.

Brian Hetzell, M.S.

Mr. Hetzel has over 7 years experience in performing and supporting statistical analyses in both the pharmaceutical and medical device industries.  He has worked on Phase I, II, and III pharmaceutical studies; and supported large multi-site device studies that have resulted in successful approval.  Mr. Hetzell serves as a lead statistician for projects, performs statistical consulting, develops analysis plans and protocol statistical sections; and is an integral part of client support for multiple companies.

Mr. Hetzell has been an author on journal publications and attended numerous medical device seminars including Bayesian and Adaptive design.  Mr. Hetzell has also attended FDA meetings to provide statistical representation.

Mr. Hetzell earned a M.S. in Mathematics with a concentration is Statistics from the University of North Carolina at Wilmington.

Stephanie Williams, B.S.

Ms. Williams has over 7 years of experience with clinical trials in the pharmaceutical and medical device industries.  She has been instrumental in the development of the Stat-Tech Services, LLC, data management department.  Ms. Williams oversees studies ranging from small pharmaceutical projects to large medical device studies.  She is familiar with handling study sites outside of the United States.  In addition to leading our data management department, Ms. Williams is an experienced SAS Programmer which adds to her extensive knowledge of building databases.

Ms. Williams assists clients with their case report form design, database development and database validation.  Once a project is initiated, she continues to regularly communicate with clients and sites to identify and resolve data issues that arise during data collection.

Ms. Williams earned a B.S. in Mathematics from the NC State University.