HASUG MEETING ANNOUNCEMENT AND DIRECTIONS - Thursday Feb 27th, 2014

[Charles Patridge]

HASUG MEETING ANNOUNCEMENT AND DIRECTIONS

NEXT HASUG MEETING ANNOUNCEMENT 
Our next meeting is on: Thursday, February 27, 2014 
at Orange Library ~ Case Memorial Library 
176 Tyler City Road 
Orange, CT 06477 

NOTE!!! difference in time from 10:00 am to 1:00 pm 

Registration will be open until noon on Wednesday, February 26th. 
Refreshments to be served and time for conversation beginning at 10:00 am. 

Our Topics and Speakers will be:

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FOILING FRAUD: THE USE OF ANALYTICS IN CREDIT CARD FRAUD DETECTION AND PREVENTION

Kathleen Alber, Service National Corporation

Credit card fraud results in card issuer losses of billions of dollars each year, and with each passing year, the amount lost and the variety of fraudulent methods increase. Obviously, detection and prevention of fraud is of pressing concern to the financial institutions which issue the cards, the merchants who accept them as well as the card holders who fall victim to fraudulent schemes. With news reports of data breaches and phone calls from banks alerting us to the very real possibility that we may be personally affected by fraudulent card activity, it's natural that those of us who deal regularly with data be curious as to how software tools like those from SAS are used to create solutions which defend us against fraudsters. This presentation provides an overview of the analytic process used to detect and prevent fraudulent credit card activity.

Kathleen Alber is a predictive data analyst at Service National Corporation. Her work involves descriptive and predictive modeling of bank credit card data in support of multiple functions for 1st Financial Bank USA including risk, finance, marketing, and fraud detection/prevention. In the past, Kathleen has worked as a systems programmer and software engineer. She holds an undergraduate degree in Mathematics from Sacred Heart University, an M.E. in Biomedical Engineering from the University of Virginia, and an M.S. in Data Mining from Central Connecticut State University.

Could Have, Would Have, Should Have! Adopting Good Programming Standards, Not Practices, to Survive An Audit.

Vincent J. Amoruccio, M.A., Alexion Pharmaceuticals, Inc., Cheshire, Connecticut

The primary purpose of a Pharmaceutical is to develop and market drugs which treat or prevent disease safely and efficaciously. A major step in the licensing of a drug, in particular in the United States, is the inevitable audit by the FDA. While the FDA suggests that adherence with Good Clinical Practices (“GCP”) is a critical requirement, it falls short in providing programming standards for the SAS® deliverables of a submission. SDTM and ADaM are solutions to standardizing the review of data, but not the programs themselves. The lack of regulations leaves programmers unmanaged and exposed to risk when asked to deliver SAS® Programs to the FDA during a submission. While many programmers are addressing this through groups, papers, websites, and blogs there are no formal Good Programming Practices (“GPP”). Until there is, programmers must create, manage, and defend their own programming choices during an audit. It is not enough to establish programming practices since auditors only care about what was done rather than what could have, would have or should have been done. This paper will first discuss the importance for GPP and common practices appearing in current GPP discussions. It will then discuss the difference between practices and standards and suggest ways to select practices to manage as standards. It will suggest ways to check and document compliance with Good Programming Standards (“GPS”), not GPP, and prepare for a successful FDA Audit. Finally, it will end with a call to the FDA for established programming standards.

Vincent J. Amoruccio, Director of Clinical & Statistical Programming at Alexion Pharmaceuticals has experience providing direct project, team and staff oversight, a strong Senior Programming background, a Master’s Degree in Biostatistics, CDISC SDTM training and 8 solid years of SAS experience including SAS/BASE, SAS/ACCESS, SAS/MACRO, SAS/STAT, SAS/SQL and SAS/GRAPH. He is highly proficient in using SAS statistical procedures to produce tables, listings, figures, statistical analyses and modeling including simultaneous modeling of discrete and continuous variables. Also experienced in all aspects and phases (I-IV) of Clinical Trials, epidemiology studies and authoring parts of SAPs and SOPs. Therapeutic experience includes autism, cardiovascular, diabetes, gastrointestinal, infectious diseases, rare fatal diseases, obstetrics and gynecology, oncology and sexual health.

Please invite your colleagues to join us BUT you and they must register first.  Meeting directions can be found on the HASUG website.

The HASUG FLASH is available for reading - where else???  at www.hasug.org 

Please consider hosting one of our future meetings, or jump start your career by presenting a topic at a future meeting.  Just contact one of the HASUG steering committee members for more information.

See you all this coming Thursday at 10:00 AM 

The HASUG Steering Committee

www.hasug.org