Rho Principal Investigators

Our Principal Investigators' passion for science makes us leaders in federally and commercially funded research

Rho Principal Investigators (PIs) must balance being leaders, researchers, authors, communicators, problem solvers, and mentors. It's these characteristics that make it possible for our partners in federally funded and commercial projects to trust that we will assist them in their research endeavors. The work of our Principal Investigators enhances the scientific reputation of our company.

Rho Principal Investigators have guided the work of statistical and data management coordinating centers (SDMCs) involved in more than 80 federally sponsored studies at over 600 sites with almost 50,000 trial participants. Every year, Rho Principal Investigators contribute to the greater scientific community by sharing the results of these studies in peer-reviewed publications and at industry events.

Our PIs continually drive the growth of our expert staff by mentoring future Principal Investigators. During the mentoring process, these future PIs serve for 2 to 3 years as co-Principal Investigators under their mentor. Through this process, Rho provides constant development and reinforces the highest degree of scientific integrity in its future work and staff.

Working in parallel with our Principal Investigators, Rho's teams get a greater level of exposure to science-driven federal research. This scientific immersion helps set Rho apart from other CROs. It provides our people with knowledge they can apply to commercial work and enhances their ability to become industry leaders in federal and commercial research.

• Ronald W. Helms, Ph.D.
  Chairman and Co-founder
• Herman Mitchell, Ph.D.
  Vice President, Federal Operations
• Samuel J. Arbes Jr., D.D.S., Ph.D.
  Senior Research Scientist
• Gloria David, Ph.D., M.H.Sc.
  Research Scientist
• Sharyne Donfield, Ph.D.
  Senior Research Scientist

• David Ikle, Ph.D.
  Senior Statistical Scientist
• Karen Kesler, Ph.D.
  Assistant Director, Biostatistics
• Lynette Keyes-Elstein, Dr.P.H.
  Senior Statistical Scientist
• Nancy Yovetich, Ph.D.
  Senior Research Scientist
• James Rochon, Ph.D.
  Senior Statistical Scientist

Ronald W. Helms, Ph.D.

Chairman and Co-founder

Read Dr. Helms' CV here.

More than 10 years before co-founding Rho, Ron Helms had already been working as a Principal Investigator for a National Institutes of Health (NIH)–funded study. In 2008, the Rho chairman concluded work on his 14th project as a PI. In leading these programs, Dr. Helms has explored a broad range of treatment areas including allergy, asthma, autoimmune disease, infectious diseases, lung injury, mental health, and sickle cell disease.

Over the course of his career, Dr. Helms' participation and achievements have made him one of the most respected voices in modern biostatistics. He's been a member of 10 professional societies and has held eight elected positions and nine appointed offices in professional statistical organizations. Ron has served on nine advisory committees for the federal government and other national organizations. In addition to being a faculty member since 1968, Dr. Helms has also participated in or directed numerous advisory, public health, and biostatistics committees for the University of North Carolina at Chapel Hill (UNC-CH).

He has shared his expertise in statistical analyses, data management, and computer systems with state and national organizations and less developed countries in Central and South America and Eastern Europe. Dr. Helms designed pioneering statistical analysis programs and data management systems that include some of the first interactive programs to receive widespread use by leading universities and industries across the United States. He has authored or co-authored more than 120 peer-reviewed papers and publications. His commitment to the clinical research industry reflects extraordinary contributions to the advancement of statistical and medical sciences.

Herman Mitchell, Ph.D.

Vice President, Federal Operations

Read Dr. Mitchell's CV here.

Herman Mitchell has established his credentials as a Principal Investigator in coordinating some of the largest clinical research projects ever awarded by the NIH. Under Dr. Mitchell's leadership, Rho is serving as the statistical and data coordinating center for clinical and non-clinical research activities of the Immune Tolerance Network (ITN). This project includes the participation of 70 distinguished investigators from more than 50 institutions around the world. The ITN's objective is to accelerate the evaluation of promising approaches for the introduction and maintenance of immune tolerance.

For 26 years, Dr. Mitchell has been coordinating large, multicenter studies for the NIH in treatment areas including cardiovascular disease, HIV, and cognitive function for older adults. Today, Dr. Mitchell continues to coordinate groundbreaking research for the Inner-City Asthma Study (ICAS), an 18-year study on asthma and inner-city children. Physician and environmental interventions in the study have yielded positive results, such as reduced emergency department asthma visits and decreased reported symptoms. He has also worked with the National Cancer Institute to establish coordinating centers in Belarus and Ukraine for studies focusing on the human impact of the Chernobyl disaster.

Samuel J. Arbes Jr., D.D.S., Ph.D.

Senior Research Scientist

Read Dr. Arbes' CV here.

Samuel Arbes, a dentist and oral epidemiologist, has experience working not only in oral health research but in the field of allergy and asthma. Before joining Rho, Dr. Arbes was a scientist with the National Institutes of Environmental Health Sciences, where his work included the design implementation and management of observational and clinical studies involving indoor allergens and allergic diseases. Dr. Arbes joined Rho in 2007 to provide expertise in oral health and allergic disease for the company's federal and commercial projects. For several years, Dr. Arbes led the Clinical Research Operations and Management Support (CROMS) contract, which provides comprehensive clinical research operations support, management, and data coordinating services for clinical research sponsored by the National Institute of Dental and Craniofacial Research (NIDCR). Dr. Arbes currently serves as principal investigator for the Inner City Asthma Consortium (ICAC), a federal contract that provides research support in the field of allergy and asthma.

Dr. Arbes was a Clinical Research Fellow and Oral Epidemiology Fellow at the University of North Carolina at Chapel Hill (UNC-CH). He practiced dentistry for 10 years and is an adjunct associate professor at UNC-CH.

Gloria David, Ph.D., M.H.Sc.

Research Scientist

Read Dr. David's CV here.

Gloria David is a talented, accomplished research scientist with an impressive resume of honors and awards such as the Intramural Research Training Award from the National Institute of Environmental Health Sciences (NIEHS) and the Fellows Award for Research Excellence from the NIH. Since joining Rho in 2004, Dr. David has served as co-PI of the statistical and clinical coordinating center for the NIAID-funded Inner-City Asthma Consortium (ICAC) and as the Principal Investigator of the statistical and data coordinating center for the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) and the Atopic Dermatitis Research Network (ADRN).

Before coming to Rho, Dr. David completed two post-doctoral fellowships. At Johns Hopkins University Department of Oncology, she conducted drug resistance research in prostate and breast cancer. Later, she completed a fellowship at the National Institute of Environmental Health Sciences, examining genetic and environmental susceptibility to asthma and lung cancer. During her second fellowship, she completed the Duke University Clinical Research Training Program.

Sharyne Donfield, Ph.D.

Senior Research Scientist

Read Dr. Donfield's CV here.

Dr. Sharyne Donfield, an epidemiologist and an expert in the coordination of multicenter studies of coagulation disorders, has authored or co-authored more than 50 papers and publications. Her interests include factors that affect physical growth, development, and academic achievement in children and adolescents with hemophilia, the use of prophylaxis to treat hemophilia and von Willebrand disease (VWD), and the development of inhibitory antibodies in response to clotting factor replacement therapies.

For 20 years, Dr. Donfield has directed data and statistical coordinating center activities for multicenter studies including the Hemophilia Growth and Development Study funded by the NIH, National Institute of Child Health and Human Development (NICHD). Currently, she heads the coordinating center for the international multicenter Hemophilia Inhibitor Genetics Study (HIGS), a collaborative effort of industry, government, and academic scientists to address genetic factors associated with the development of inhibitory antibodies to factor VIII, one of the most important complications of hemophilia A. She also directs the multicenter von Willebrand Disease Prophylaxis Network (VWD PN), an international study group investigating the role of prophylaxis in clinically severe VWD.

David Ikle, Ph.D.

Senior Statistical Scientist

Read Dr. Ikle's CV here.

David Iklé has more than 25 years experience as a senior biostatistician in a variety of areas of application, including manufacturing research and development, statistical process control, clinical trial design and analysis, and bioinformatics. Prior to joining Rho, he was Director of Biostatistics and Academic Computing at National Jewish Health and a senior faculty member in Biostatistics at the University of Colorado Health Sciences Center in Denver, CO. He was also Director of Biostatistics at the City of Hope Comprehensive Cancer Center and senior faculty member in the Beckman Research Institute in Duarte, CA. He has served on numerous peer review committees of the NIH reviewing grant applications in allergy, asthma, oncology and organ transplantation and has co-authored more than 50 peer-reviewed publications in clinical and translational science. This varied background has made Dr. Iklé very well suited to assume senior leadership roles in NIH-funded consortia performing clinical, proteomic and genomic studies in immunologic disorders.

Since joining Rho Federal Systems in 2009, Dr. Iklé has become Co-PI of the Statistical and Data Coordinating Center (SDCC) for the Immune Tolerance Network (ITN), responsible for biostatistical leadership of its clinical trials in solid organ transplantation. In addition, he is PI of the Statistical and Clinical Coordinating Center (SACCC) for three consortia funded by the National Institute of Allergy and Infectious Diseases (NIAID): Clinical Trials in Organ Transplantation (CTOT), Clinical Trials in Organ Transplantation in Children (CTOT-C) and the Genomics in Transplantation Cooperative Research Program (GTCRP). He is also a Co-Investigator on two NIAID-funded grants responsible for developing biomarkers predictive of rejection in kidney transplant recipients and a central large-scale data archive for high dimension genomics data and high resolution biopsy pathology images and flow cytometry data. As a result, he is at the forefront of NIH-funded clinical and translational research in solid organ transplantation, providing biostatistical leadership for more than 25 clinical and observational studies designed to improve clinical outcomes from transplants, to reduce the burden on patients of immunosuppressive medications, and to develop genomic and proteomic biomarkers predictive of long term transplant survival.

Karen Kesler, Ph.D.

Assistant Director, Biostatistics

Read Dr. Kesler's CV here.

Karen Kesler is a gifted statistician, adaptive design expert, and respected leader at Rho and in the clinical research industry. An adjunct professor of biostatistics at the University of North Carolina at Chapel Hill, Dr. Kesler has a passion for quality research and biostatistics. Her invaluable experience at Rho and 10-year history of sickle cell disease research serves her well as co-PI of the Statistical and Data Management Center for the Sickle Cell Basic and Translational Research Program. She also has experience working on oncology and cardiovascular studies.

Dr. Kesler has a passion for making studies more effective. Her expertise in study design informs an advanced insight that allows her to provide expert guidance to stakeholders. If a concept is limiting, she has an ability not only to identify it but also to help all stakeholders understand the inherent possibilities of another concept. Whether she's developing novel adaptive study designs, helping sponsors meet their specific research goals, or improving existing tools and developing new ones to facilitate project implementation, Dr. Kesler is always finding ways to enhance clinical research. She is also the co-PI for the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) for which the primary goal is to advance clinical research in the development of safer smallpox vaccines for individuals with atopic dermatitis (AD).

Dr. Kesler is also the author of Rho's Adaptive Design blog, which covers topics such as FDA preferences, regulatory concerns, biostatistical considerations, and protocol implementation logistics for studies using Adaptive Designs.

Lynette Keyes-Elstein, Dr.P.H.

Senior Statistical Scientist

Read Dr. Keyes-Elstein's CV here.

Lynette Keyes-Elstein welcomes challenges and thrives on finding solutions for difficult problems. To conquer obstacles such as finding creative ways to analyze data and coordinating project activities across departments to rein in expenditures, she draws on both statistical expertise and exceptional management skills. Dr. Keyes-Elstein holds graduate degrees in both biostatistics and immunology and has published peer-reviewed articles as a biostatistician and as a bench scientist. Her background of scientific and biostatistical achievement enhances her ability to provide meaningful statistical consultation on design and analysis issues associated with studies of diseases and conditions with underlying immunologic mechanisms.

After serving as a co-PI of the Statistical and Clinical Coordinating Center for Autoimmune Disease Clinical Trials (SACCC-ADCT) for 6 years, Dr. Keyes-Elstein took over as Principal Investigator and head of Rho's department of infectious and autoimmune diseases in 2008. She is also a co-PI for Rho's Statistics and Data Coordinating Center for the ITN. As a reward for her efforts, Dr. Keyes-Elstein has won Rho's Presidential Award for Reaching Above and Beyond three times since 2005.

Nancy Yovetich, Ph.D.

Senior Research Scientist

Read Dr. Yovetich's CV here.

Nancy Yovetich is the Principal Investigator of the Clinical Research Operations and Management Support (CROMS) services program, which is a sole-source, clinical research services contract with the National Institute of Dental and Craniofacial Research (NIDCR). Through the contract, Rho provides ongoing study services in one or more of the following areas: protocol writing, clinical monitoring, data management, biostatistics, project management, safety reporting, regulatory support, website and other software development and support, scientific consultation, and tools and other infrastructure development. The greater than 30 supported studies have a wide range of clinical indications such as Sjögren’s syndrome, severe refractory cancer pain, FGF-23 mediated hypophosphatemia, hypoparathyroidism, screening for acute myocardial infarction, oral cancer lesions, and oral health. Dr. Yovetich also serves as the leader (Co-PI) of the statistics and data management center for an NHLBI-funded stroke prevention study: Stroke With Transfusions Changing to Hydroxyurea (SWiTCH). This is a safety and efficacy study comparing standard and alternative therapies for the prevention of secondary stroke and reduction of iron overload in pediatric subjects with sickle cell anemia. The SWiTCH study is closed, and the project is now in the manuscript writing phase.

Prior to becoming a PI on federally funded projects, Dr. Yovetich was a project leader on commercially funded clinical trials. During those years, she also led both the Project Management and Medical Writing departments at Rho.

James Rochon, Ph.D.

Senior Statistical Scientist

Read Dr. Rochon's CV here.

James Rochon received his Ph.D. in Biostatistics from the University of North Carolina at Chapel Hill in 1985. He is an experienced biomedical investigator, and over the years has gained considerable experience in a variety of medical studies leading to publications in the and elsewhere. From 1994 to 2002, he was an Associate Research Professor at the Biostatistics Center of the George Washington University. There, he collaborated on a number of large, multi-center clinical trials under the direction of senior investigators including Dr. John Lachin. From 2002 to 2010, he was a Research Professor in the Duke University Medical Center. He served as the PI for the Statistics and Data Coordinating Center (SDCC) in the Girls health Enrichment Multi-site Studies (GEMS) funded by the NHLBI, the Comprehensive Assessment of the Long-term Effects of Reducing Intake of Energy (CALERIE) funded by the NIA, and the Drug-Induced Liver Injury Network (DILIN) funded by the NIDDK. He also served as the PI for a methodological grant to develop statistical techniques for longitudinal studies. Dr. Rochon has authored and co-authored more than 66 peer-reviewed publications in biomedical and statistical journals including the New England Journal of Medicine, Journal of Immunology, Transplantation, Biometrics, Journal of the American Statistical Association, and Journal of the Royal Statistical Society.

Dr. Rochon currently serves as a PI for the SDCC of the Immune Tolerance Network funded by the NIAID. The purpose of the network is to perform detailed investigations on how the immune system responds to outside pathogens with a view towards developing effective interventions to promote “tolerance” to these pathogens. There are currently more than 20 clinical trials either in development or actively following study participants in the fields of allergy, asthma, autoimmune disease and solid organ transplantation. Under Dr. Rochon’s direction, RhoFED performs critical activities including statistical design and analysis, clinical data management, randomization, safety oversight, and clinical study web site development and maintenance.

Rho offers a comprehensive range of CRO capabilities.

Diverse opportunities await you at Rho.