staff
The EMMES Corporation
 

SENIOR INVESTIGATORS

 
 
Donald Stablein  


Donald Stablein, Ph.D.
President

Dr. Stablein, President, brings a distinguished record as a statistician to the lead position at The EMMES Corporation. His professional stature is reflected in his many current activities. Dr. Stablein is a statistical editor of the Journal of the National Cancer Institute and a fellow of the American Statistical Society. He serves as a member of the Data and Safety Monitoring Board of the National Institute of Child Health and Human Development Maternal Fetal Medicine Network and is chairman of the National Cancer Institute’s Intramural Data and Safety Monitoring Board. He was appointed by the Secretary of Health and Human Services to serve on the National Advisory Commission on Organ Transplantation. He has over 100 publications to his credit.

After receiving his Ph.D. in biostatistics from the Medical College of Virginia, Dr. Stablein began his career there as an assistant professor in biostatistics. He joined EMMES in 1980 as a staff statistician; in 1992 he became president of the company.

Dr. Stablein has served as Principal Investigator for a pediatric renal transplant registry that involves 100 clinics. In that same capacity he directed a project evaluating AIDS vaccines and an investigation of gastrointestinal cancer, both sponsored by the NIH, and both having more than 50 protocols.

Dr. Stablein’s position as President of The EMMES Corporation provides assurance that the company activities are firmly rooted in a sound scientific base.

Dr. Stablein is an active member of The Biopharmaceutical Applied Statistics Symposium (BASS) and is on the 2005 Program Committee.

 

 
Anne Lindblad  


Anne Lindblad, Ph.D.

Executive Vice President

As Executive Vice President at EMMES, Dr. Lindblad serves the company with more than 20 years of combined experience in biostatistics, clinical design, and project management.

Dr. Lindblad holds a Ph.D. in statistics from the George Washington University, and a master's in biostatistics from the Medical College of Virginia. She is the author or co-author of more than 100 publications and oral presentations. Her professional leadership ability is illustrated as a member or chair of Data and Safety Monitoring Committees for the National Eye Institute (NEI) and for the National Institute on Alcohol Abuse and Alcoholism. Dr. Lindblad has been, and currently is, a reviewer of NIH grant and contract applications from multiple NIH Institutes. She has served as an elected member of the Board of Directors for the Society for Clinical Trials, and as the Program Chair for that organization.

Dr. Lindblad has been the Coordinating Center PrincipaI Investigator for major NEI efforts including large, multi-center Phase III clinical trials and NEI intramural Phase I and II trials. She has led an industry-sponsored pediatric liver transplantation registry and a multi-protocol statistical and data coordinating center program for the National Institute on Deafness and Other Communication Disorders. She also provides corporate oversight for both industry- and government-sponsored projects within the company.

Dr. Lindblad contributes to the successful execution of The EMMES Corporation's activities through her expertise and experience in clinical trials and through the active promotion of effective liaisons with sponsors and study participants.

Dr. Lindblad serves as a member on the National Advisory Dental and Craniofacial Research Council of the National Institute of Dental and Craniofacial Research until December 2008.

 

 
Shelly Carter  


Shelly Carter, Sc.D.

Vice President

Dr. Carter earned the Sc.D. degree in biostatistics from Harvard University, her M.S. from the University of Texas and her B.S. degree from the University of Houston. While in Houston, over a four year period, she was the Data Systems Coordinator for the Southwestern Oncology Group and Department of Hematology at the M. D. Anderson Cancer Center. She also worked as a statistical analyst/programmer for the Department of Pediatrics at the University of Texas Medical School.

After receiving her doctoral degree in 1993, Dr. Carter brought her experience and academic qualifications to The EMMES Corporation, where she is the principal investigator for the T-Cell depletion trial, a project that involves 14 centers. She is also PrincipaI Investigator for a study of cord blood transplantation, with over 20 participating centers, and for the Blood and Marrow Transplantation Clinical Trials Network. Her work includes protocol development, statistical design, and coordination of multiple hospitals and laboratories.

Dr. Carter is on the Regional Advisory Board of the Eastern North American Region of the Biometric Society and is a member of the American Statistical Association. She also serves on two Data Safety and Monitoring Boards for the National Heart, Lung, and Blood Institute at NIH and the NHLBI Clinical Trials Review Committee.

 

 
Traci Clemons  


Traci Clemons, Ph.D.
Vice President

Dr. Clemons holds PhD and Masters level degrees in Biostatistics from the University of Alabama at Birmingham. Prior to joining EMMES in 1999, Dr. Clemons was an Assistant Professor at the University of Mississippi Medical Center and completed a postdoctoral fellowship at the Harvard School of Public Health. At EMMES, Dr. Clemons serves as Principal Investigator for numerous Statistical and Data Coordinating Centers sponsored by the government and private pharmaceutical corporations in a variety of disease areas, such as age related macular degeneration, cataract, macular telangiectasia, and autism spectrum disorders.

Dr. Clemons has been an active scientific voting member of The EMMES Corporation's Institutional Review Board since 2000. Dr. Clemons is also a member of a National Institute of Child Health and Human Development Obstetrics and Maternal-Fetal Biology Subcommittee and the Genomic and Proteomic Network for Premature Birth Research Advisory Board. She also serves as the Chairperson for the Data Safety Monitoring Board for the Muscular Dystrophy Cooperative Research Centers.

Dr. Clemons is active in protocol design and implementation, statistical analyses, form design and development, and developing and writing study reports, abstracts and manuscripts for publications. Dr. Clemons also has numerous peer reviewed professional publications to her credit.

 

 
Marian Ewell  


Marian Ewell, Sc.D.

Vice President

Dr. Ewell’s academic background in statistics began with a bachelor of science degree at Princeton and continued with a master’s degree from the University of Wisconsin. She earned the Sc.D. degree in biostatistics at Harvard University. She continued post-doctoral studies at the Harvard School of Public Health and the Dana-Farber Cancer Institute before coming to EMMES in 1994. As a post-doctoral fellow, she was the statistician for the Melanoma Committee of the Eastern Cooperative Oncology Group and did research in survival analysis.

As Director of Statistical Research, Dr. Ewell is responsible for evaluating and implementing new and existing statistical methodologies within EMMES' research projects. Dr. Ewell has served as the PrincipaI Investigator for large and complex programs encompassing statistical components of clinical trials, protocol compliance, regulatory requirements, data audits, data management, and other coordinating center tasks.

Dr. Ewell has been awarded a number of fellowships and scholarships and is a member of the Biometric Society and the American Statistical Association.

 

 
Paul VanVeldhuisen  


Paul VanVeldhuisen, Ph.D.

Vice President

Dr. VanVeldhuisen, epidemiologist, provides statistical expertise and managerial leadership to both government-sponsored and privately funded projects at EMMES. As Director and PrincipaI Investigator of the National Eye Institute-sponsored Coordinating Center for the Advanced Glaucoma Intervention Study (AGIS), he has responsibilities for staffing, budget, data analyses, monitoring clinical sites, and data management of this multi-center project. His duties as a member of the AGIS Operations Committee include assessing data quality, monitoring protocol adherence and writing of manuscripts.

In addition, Dr. VanVeldhuisen serves as the PrincipaI Investigator for two privately funded research studies, one that investigates different regimens for immunosuppressive therapies in cardiac, kidney and liver transplantation, and the other is a large pediatric registry of infants at risk for respiratory infection. These efforts involve study design as well as monitoring and analysis of data.

Dr. VanVeldhuisen earned his doctoral degree in epidemiology from the George Washington University in Washington, D.C., and holds a master's degree in biostatistics from the University of Washington in Seattle.

 

 
Mark C. Wolff  


Mark C. Wolff, Ph.D.

Vice President

Dr. Wolff’s primary area of concentration is infectious diseases with substantial experience in all phases of clinical vaccine development. Among his achievements in this area are the design and analysis of Phase III clinical trials that were pivotal in obtaining FDA licensure.

In 1994, Dr. Wolff joined EMMES as Co-Principal Investigator on an AIDS vaccine evaluation study. Later, he became the Principal Investigator for a clinical and epidemiology contract in infectious disease that involved large, pivotal Phase III studies in influenza and genital herpes, and Phase I, II, III and IV studies of syphilis, vaccinia, cytomegalovirus, Lyme disease, herpes labialis, pneumococcal disease, vaccinia, pediatric combination vaccines, malaria and chronic fatigue syndrome. Dr. Wolff’s team also provided technical reviews for the International Collaboration in Infectious Diseases Research.

Dr. Wolff earned his Ph.D. in mathematics at the State University of New York at Stony Brook. Prior to joining EMMES, his professional experience included a joint faculty appointment at the Johns Hopkins School of Hygiene and Public Health Departments of International Health and Biostatistics. In this appointment he was the Co-Principal Investigator and statistician for a pivotal Phase III trial of a Haemophilus Influenzae vaccine, statistician for epidemiologic studies of diarrheal diseases and provided on-site consultation to clinical studies in Indonesia, Costa Rica, Peru and Guatemala. Prior to his work at Hopkins, he was the lead statistician for the Neuroclinical Trials Center at the University of Virginia.

 

 

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