Charles Wakeford, PhD
Managing Member, Statistics
Chuck is a co-founder of Triangle Biostatistics. With 29 years of experience working in the pharmaceutical industry, he has provided statistical leadership in every phase of drug development. His experience includes protocol development, study design, sample size determination, and generation of randomization schedules. He has provided leadership for multiple regulatory submissions and has collaborated with many regulatory agencies worldwide. Chuck’s experience spans working with clinical research, data management, medical writing, clinical compliance, regulatory affairs, sales, and marketing personnel.
Managing Member, Programming
Chan is a co-founder of Triangle Biostatistics, and has over 22 years of experience in the industry as a SAS® Programmer. He has successfully managed programming groups at CROs and pharmaceutical companies, where he also worked on regulatory submissions for clinical development programs spanning multiple indications and multiple programming environments. Chan has also been responsible for leading the work of an applications development group at a large biotech company where he developed SAS® macros to support regulatory submissions and also developed other customized non SAS®-based utilities.
Jeff Sorbel, MS
Managing Member, Statistics
Jeff is a co-founder of Triangle Biostatistics, and has over 21 years of experience in the pharmaceutical industry. His experience includes 5 regulatory submissions seeking marketing authorization for various compounds. Jeff has interacted with major regulatory agencies worldwide, and has been involved with protocol development, study design, sample size determination, generation of randomization schedules, and authoring statistical analysis plans for numerous indications. He also has experience working with clinical research, data management, medical writing, clinical compliance, regulatory affairs, sales, and marketing personnel.
Executive Director of Business Operations
Kathy is a proven clinical research business executive and leader with a career that spans more than 25 years in large and small CROs, as well as pharmaceutical and government research companies. Her experience has included founding and growing a niche CRO, leading an international clinical services company, driving integration for a global multi-company merger, leading global recruiting, building departments and teams, process development and improvement, and leading business operations functions such as proposals, contracts, finance, and business development.
Prior to joining Triangle Biostatistics, Kathy held the position of Executive Director, Clinical Analytics at Chiltern International where she was responsible for managing the business portfolio for Resourcing Solutions and overseeing Global Talent Acquisition. Other key roles Kathy has held include Principal and Co-founder of niche CRO INNO Clinical Outcomes, and President of Trio Clinical Resourcing.
Kathy holds a Bachelor’s Degree in Economics from the University of Illinois and a Master’s Degree in Management from North Carolina State University.
Director of Data Management
Susan has more than 30 years’ experience with leadership in clinical trial operations, specializing in clinical data management. Her areas of experience include clinical programming, planning and contracting, clinical operations, and information technology (managing all systems for clinical trial operations, including pharmacy operations, randomization, data management, and clinical trial management). Prior to Triangle Biostatistics, Susan was Founder of CDM Advisor, Ltd, a data management consulting firm and before that was Senior Director of Clinical Data Services at Cato Research. She has specialized experience in government contracts with the National Institutes of Health, specifically with the Division of Acquired Immunodeficiency Syndrome; the National Heart, Lung, and Blood Institute; the National Cancer Institute, National Institute of Allergy and Infectious Diseases, and the Immune Tolerance Network. Throughout her career, Susan has actively participated in preparing data for many NDAs, the first and second, azidothymidine (AZT), for the treatment of AIDS (1987) and tacrine (Cognex) for the treatment of alzheimer’s (1993). At Triangle Biostatistics, Susan is an active member of the senior management team and is responsible for leading the global data management. In this role she manages all resources and finances for the group, defines policies and procedures, leads projects and project teams, and ensures clients receive the best service possible. Susan holds a Bachelor’s Degree Psychology from Eastern Michigan University and a Master’s Degree in Business from Averett University in Virginia. She is also a Certified Clinical Data Manager (CCDM) with the Society for Clinical Data Management.
Director of Statistics
Caroline has over 12 years of experience in the clinical trial industry working in mid-sized CROs and private consulting companies. Caroline has experience in all phases of clinical development, with a significant amount of experience in the analysis of pharmacokinetic and pharmacodynamics data for Phase I clinical trials. Her experience includes study design, sample size determination, generation of randomization schedules, statistical programming and authoring statistical analysis plans.
Prior to joining Triangle Biostatistics, Caroline worked for 5 years as a Senior Biostatistician at Chiltern International. She served as lead statistician on several studies in a variety of therapeutic areas and contributed to a successful BLA submission in the treatment of hemophilia B. In addition, Carolina worked at AAIPharma and Biostudy Solutions LLC for a total of 7 years, leading the statistical teams responsible for the analysis of Phase I bioequivalence and bioavailability studies. She has extensive knowledge in the design of these studies and the analysis of pharmacokinetic data, as well as contributing to numerous successful ANDA and NDA submissions. Caroline earned her MS in Mathematics with a concentration in Statistics from UNC-Wilmington.
Executive Director of Statistical Programming
With over 19 years of experience working in the clinical trial industry, Laura has worked in large and small pharma and CRO environments and has accrued a wealth of knowledge of the biostatistics and data management landscapes. Her technical skills in statistical programming, data management, SAS® programming, and CDISC, combined with her functional management and leadership background allow Triangle Biostatistics to identify and place the highest caliber staff with our clients. Laura’s expertise provides additional benefit with respect to talent acquisition, as she routinely takes a hands-on approach with Triangle Biostatistics’ contractors and our clients regarding training, troubleshooting, and consulting arrangements.
Laura’s background spans large pharma (GSK), large CRO (Quintiles and PPD), mid-size CRO (Theorem/Chiltern), and small CRO (head of statistical programming for Statworks [now PharmOlam]), with experience across multiple therapeutic areas and all phases of clinical development. For example, Laura played an integral role in the successful submission of Lamictal®, the first FDA-approved therapy since lithium for maintenance of bipolar disorder.
In 2008, she developed CDISC expertise and became involved with local CDISC groups, as well as the CDISC Interchange and PhUSE. Laura co-authored and presented a paper on Integrated ADSL for PhUSE in 2011 and co-developed a presentation on RELREC for CDISC Interchange in 2012. She joined the local North Carolina CDISC Steering Committee and later became co-chair. She is now an active member on the national CDISC Advisory Committee. Laura earned her BS in Mathematics from UNC-Wilmington.
Director of Statistical Programming
Spencer (Spence) has over 20 years of SAS programming experience in both CROs and pharma companies in Phases I-IV. He has experience in multiple therapeutic areas including asthma, oncology, seasonal allergic rhinitis, sinusitis, HIV/AIDS, HBV, HCV, pain management/analgesia, diabetes, and MS. Spence has experience preparing successful NDA submissions, including integrated summaries of safety and integrated summaries of efficacy. He has extensive knowledge of CDISC standards. He has strong management experience and excellent communication skills.
Director of Biostatistics
Paul has over 15 years of experience in the clinical trial industry working in large and mid-sized CROs as well as an ARO. Paul has experience in all phases of clinical development, with a significant amount of experience in the analysis of clinical trial data for Phase II and Phase III clinical trials. His experience includes protocol development, study design, sample size determination, generation of randomization schedules, authoring statistical analysis plans and directing the biostatistical activities of large multi-protocol programs. He has also co-authored over 30 publications in peer-reviewed medical journals.
Paul’s background spans large CRO (Quintiles and INC Research), mid-size CRO (Novella Clinical and SynteractHCR), and ARO (Duke Clinical Research Institute), with experience across multiple therapeutic areas including Autoimmune Diseases, Cardiology, CNS, Infectious Disease and Oncology.
Paul holds a Bachelor’s of Science Degree with a major in Statistics from Colorado State University and a Master’s of Statistics Degree from North Carolina State University.