Our Team.

Industry Experience:
26+ years of experience in Biometrics, Clinical Data Management, Clinical Operations, and Outsourcing.

Industry Experience:
Industry Experience:
26+ years of experience in Biometrics, Clinical Data Management, Clinical Operations, and Outsourcing.

Industry Experience:
Over 20-years of Biometrics leadership experience providing support solutions to pharmaceutical and biotech clients with a track record of developing sustainable and evolving relationships

Education:
MBA, Penn State University

Linkedin Profile

Profile:

Karen Curran joins Clinical Solutions Group as an executive with Over 20-years of Biometrics leadership experience providing support solutions to pharmaceutical and biotech clients that range from small startups to some of the largest global companies in the industry, and a track record of developing sustainable and evolving relationships with those clients.

At CSG, Karen leads the biometrics group and works with sponsors to develop customized solutions; from individual placements, staff augmentation strategies or developing customized FSP relationships, Karen brings her tenure of leadership experience to our clients for a solution that meets the needs and culture of every engagement.

Karen’s expertise includes CDISC compliant submissions planning and execution, developing KPIs and usable metrics in support of strategic partnerships and in managing sponsor relationships, project delivery and resourcing.

Prior to CSG, Karen led the global biometrics group of a large CRO with over 400 statisticians and statistical programmers worldwide and lead customized biometrics solutions for their key accounts.

Industry Experience:
17 years of experience in Talent Acquisition, Business Development, and Creative Recruiting Solutions

Education:
BA in Journalism

Linkedin Profile

Paul joins CSG’s leadership team bringing over 35 years of experience.  He has been involved with CDISC standards’ development since early 2000’s. His background includes contributing to the ADaM version 1.1 standard, the CDISC Breast Cancer Therapeutic Users Guide, and he is currently the co-lead of the ADaM Oncology Standards Team. In 2018 Paul served as the Academic Chair at the Pharmaceutical SAS Users Group (PharmaSUG) conference in Seattle. In this capacity, he helped to introduce sections for R and Machine Learning, and technology strategy into the curriculum.  

Deborah Nunner has 20+ years of experience in the Pharmaceutical Industry as a Principal Statistical Programmer and Standards Engineer.  Deb has been involved in the implementation CDISC standards since 2008.  Her experience spans across numerous clients with the assistance in working on their data-flow design, as well as their standards and implementation at the study, compound, and therapeutic area levels. Successfully helping to establish complete sets of standards tabulation (SDTM), analysis (ADaM), and submission (e.g.; acrf.pdf, cSDRG, ADRG, Define.xml) to regulatory agencies. Deb currently serves as a volunteer for the CDISC ADaM team as well as the current ADQRS sub-team.

Eric is a technical wizard at the creation of DEFINE.xml and ODM documents. He has created these for numerous submissions and created tools for teams to develop DEFINE documents using existing spreadsheets or metadata repositories. He has been programming in SAS for 30+ years and using CDISC standards for the last 10.

In 17+ years of experience in the Pharmaceutical Industry, Karl has been involved in implementing and designing the use of standards primarily through working with CDISC SDTM standards in 2006, as well as CDISC ADaM standards beginning around 2010. His experience spans across numerous clients with assistance in working with their data-flow design as well as standards implementation. He has successfully helped establish standards from data collection (CDASH), tabulation (SDTM), analysis (ADaM), and through submission to regulatory agencies (Define.xml). Karl currently serves as a volunteer for the CDISC ADaM team as well as the current ADaM Integration sub-team.

Nancy Brucken is an engineer in the Data Standards team for CSG with responsibility for the application of CDISC standards in clinical trials. She is a CDISC certified ADaM trainer with numerous courses that she has taught. Nancy has been a member of the CDISC ADaM standards team for the last 10 years and has contributed to the development of ADaM versions 1.1 and 1.2. She has lead the development of the ADaM Questionnaire, Ratings, and Scales team. Nancy started her career as a SAS programmer over 35 years ago transitioning into statistical programming in the pharmaceutical industry 25 years ago. She has led numerous SAS programming conferences and users groups. She is currently the Co-Chair for the PharmaSUG 2021 conference in Baltimore. When not working, she enjoys coaching and officiating volleyball games for kids.