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ADaM

Instructor: Jeff AbolafiaInstructor: Jeff Abolafia

Company: Rho, Inc

Courses Taught: ADaM

 

Jeff Abolafia is currently Chief Strategist of Data Standards at Rho, Incorporated.  Previously Jeff was a member of the faculty in the Department of Biostatistics at the University of North Carolina. Jeff has been involved with public health research and data standards for over twenty five years and is a frequent contributor and presenter at PharmaSUG, SAS Global Forum, and CDISC conferences.  Jeff co-founded the RTP CDISC User's Group and is a member of the CDISC ADaM and ADaM Metadata teams.  His areas of interest include data standards, submissions, statistical computing, and bioinformatics.

 

 

 

 

 

 

Instructor: Niels BothInstructor: Niels Both

Company: S-Cubed

Courses Taught: ADaM, SDTM

 

Having worked for more than 15 years within the different areas of clinical data flow ranging from collection to statistical analysis and submission, Niels Both provides training in CDISC standards, coupled with a unique understanding of the everyday problems encountered when submitting data in SDTM, define.xml or ADaM to FDA.

 

For the last 4 years, Niels has been working as Principal consultant for S-cubed, assisting companies across Europe implementing CDISC standards e2e ranging from CDASH over SDTM to ADaM.

 

Niels has been active in the CDISC community for almost 10 years, presenting CDISC at road-shows, conferences and other events and has also been active in e3c the European CDISC Co-ordination Committee.

 

 

Instructor: Tineke CallantInstructor: Tineke Callant

Company: SGS Life Sciences Services

Courses Taught: ADaM

 

Tineke Callant is a Senior Biostatistical Analyst at the CRO SGS Life Sciences Services.  She started working in the pharmaceutical industry in 2004 after obtaining a masters degree in biomedical sciences at the University of Antwerp.  Her daily work includes project coordination, programming analysis datasets, TLFs, and narratives together with coordinating the implementation and development of the CDISC ADaM model within the company; the latter leading to presentations at the European CDISC Interchange and FSUG events.  Tineke is a CDISC ADaM team member currently involved in ADaM PK sub team activities.

 

 

 

 

 

 

Instructor: Nate FreimarkInstructor: Nate Freimark

Company: Theorom Clinical Research

Courses Taught: ADaM

 

Nate Freimark is Senior Director of the Biometrics Operations Standards Group at Theorem Clinical Research. Nate is the current CDISC ADaM team lead, one of the ADaM instructors and a member of the SDS Oncology subteam. He has been a member of the ADaM team since 2005, a member of the ADaM Leadership Team since it’s creation, and has been “doing CDISC” since 2004. Nate is also a lead programmer who has worked on numerous projects involving the creation of SDTM and ADaM datasets and the tables, listings, and graphs created based upon them dating back to 2004. Nate has been involved in ADaM Education since it’s inception from the development of the training material to giving public, private, and FDA ADaM training courses.

 

 

 

 

 

Instructor: Monika KawohlInstructor: Monika Kawohl

Company: Accovion GmbH

Courses Taught: ADaM

 

Monika Kawohl is a Principal Statistical Programmer at the CRO Accovion and has 20 years of experience in the industry. Her daily work includes the hands-on application of CDISC standards towards submission as well as consulting clients regarding their implementation of SDTM, ADaM and define.xml. Monika joined the ADaM team in 2009 and currently contributes to the General Occurrence, Pilot 1 Update, and ADaM Metadata subteams. She is also a member of the executive committee of the German-speaking CDISC User Group.

 

 

 

 

 

 

 

Instructor: Jon RothInstructor: Jon Roth

Company: Independent Consultant

Courses Taught: ADaM

 

With over 25 years in this industry, Jon is a highly experienced consultant in pharmaceutical drug development life-cycle projects. He has been a member of the ADaM team since 2006, and since that time, most of his consultant work has focused on CDISC ADaM implementations in support of statistical programming, study integration and regulatory filing activities. Of note, he was the first authorized CDISC ADaM trainer within Europe and was responsible for the analysis data and reporting of the industry's first ADaM compliant regulatory submission to the FDA. In later years, he has been instrumental in numerous regulatory data filings with the FDA and European authorities on projects involving Lundbeck, Takeda, Forest Labs, Novo Nordisk, Merck, Abbott, Solvay, Wyeth, Novartis, and Sandoz.

 

 

 

 

Instructor: Jack ShostakInstructor: Jack Shostak

Company: Duke Clinical Research Institute

Courses Taught: ADaM

 

Jack Shostak manages a group of statistical programmers and is an Associate Director of Statistics at the Duke Clinical Research Institute.  He is the author of SAS Programming in the Pharmaceutical Industry and coauthor of Common Statistical Methods for Clinical Research with SAS Examples, Third Edition.  Jack is also coauthoring the book Implementing CDISC Using SAS: An End-to-End Guide which should be published by the end of 2012.  Jack has been active in CDISC since 2002 primarily as a contributor to ADaM model development and more recently to the Statistics Domain Analysis Model.  Jack serves as a member of the ADaM alternate leadership team and has been a CDISC ADaM instructor for industry and the FDA for the past four years.

 

 

 

 

 

Instructor: Dana SoloffInstructor: Dana Soloff

Company: Genzyme

Courses Taught: ADaM

 

Dana Soloff is a Sr. Director, Statistical Programming, at Genzyme - a Sanofi company.  She has 15+ years of experience in the pharmaceutical and healthcare IT industries.  Dana has been a member of the ADaM team since 2008 and has been on the ADaM training team since 2010.  In her work with ADaM, she also provided consistency editing on the final 2.1 Model and I.G. documents and led a team that created a first draft of an ADPC domain.  Dana’s graduate degree is in the social sciences, and prior to entering healthcare / pharma, she conducted social science and economic research for RAND, in Santa Monica, CA. 

 

 

 

 

 

 

Instructor: Mario WidelInstuctor: Mario Widel

Company: Eli Lilly

Courses Taught: ADaM

 

Mario Widel is a Research Scientist at Eli Lilly and Company.  He has been doing statistical programming since 1992. 

He has been involved in CDISC related activities since 2007 on a previous company having a key role in the transition to CDISC standards CDASH, SDTM and ADaM.  In his current role Mario oversees and participates in the metadata definition for SDTM and ADaM datasets, the design, creation and validation of TFL’s. 

He received his M.S. degree on Computer Science from the University of Illinois at Chicago. He is a regular presenter at conferences like JSM, PharmaSUG,  SAS Global Forum, PhUSE and CDISC and a member of ASA and the CDISC ADaM team.