Enhance your PharmaSUG experience by attending optional pre- and post-conference training seminars taught by seasoned experts. Half-day courses are only $125 and full-day courses are $250. You can sign up for classes when you register for the conference. Space is limited!

Be sure to review the seminar registration, attendance, and cancellation policy.

Saturday, May 31, 2014

Course Title (click for description) Instructor(s) (click for bio) Time
#1 The SDTMIG: Beyond the Modeled Domains and Other Implementation Challenges Fred Wood
& Jerry Salyers
8:00 AM - 12:00 PM
#2 PROC SQL Programming: The Basics and Beyond Kirk Paul Lafler 8:00 AM - 12:00 PM
#3 Propensity Score Methods and Uses in SAS Scott Leslie CANCELLED
#4 CDISC and XML for SAS® Programmers Lex Jansen 1:00 PM - 5:00 PM
#5 How to Leverage the Power of SAS® Enterprise Guide Scott Leslie 1:00 PM - 5:00 PM
#6 Linear Regression and ANOVA Arthur Li CANCELLED

Sunday, June 1, 2014

Course Title (click for description) Instructor(s) (click for bio) Time
#7 How (and Why) to Harmonize Data Collection with CDISC Submission Standards Steve Kirby
& Mario Widel
8:00 AM - 12:00 PM
#8 Cleaning, Validating, and Reshaping Your Data: Taking Advantage of SAS Tools Art Carpenter 8:00 AM - 12:00 PM
#9 Survival Analysis Arthur Li 8:00 AM - 12:00 PM
#10 FDA Submission Data Requirements Dave Izard 1:00 PM - 5:00 PM
#11 Getting Started with Graph Template Language Sanjay Matange 1:00 PM - 5:00 PM

Wednesday, June 4, 2014

Course Title (click for description) Instructor(s) (click for bio) Time
#12 ADaM Datasets: Creation and Applications Nancy Brucken
& Mario Widel
& Paul Slagle
1:00 PM - 5:00 PM
#13 CDI: San Diego Matt Becker CANCELLED
#14 Building Dynamic Programs and Applications Using the SAS Macro Language Art Carpenter 1:00 PM - 5:00 PM

Thursday, June 5, 2014

Course Title (click for description) Instructor(s) (click for bio) Time
#15 Advanced Reporting and Analysis Techniques for the SAS® Power User: It's Not Just About the PROCs! Art Carpenter 8:00 AM - 5:00 PM

Seminar Registration, Attendance, and Cancellation Policy

  1. You must register for the conference in order to attend a seminar.
  2. You must register for a seminar via the PharmaSUG 2014 conference registration form either by postal mail, fax, or online (preferred).
  3. You may cancel a seminar on or before May 22, 2014, and receive a full refund minus a $25 administration fee per cancelled seminar.
  4. You may add another seminar on or before May 20, 2014 without being assessed a $25 administration fee. To sign up for an additional seminar after you have already registered for the conference, please contact the This email address is being protected from spambots. You need JavaScript enabled to view it..
  5. On or before May 22, 2014, you may swap one seminar for another; however, this is considered a change in conference registration and will incur a $25 administration fee.
  6. After May 22, 2014, you MAY NOT SWAP seminars; however, a new seminar may be added depending on space and availability.
  7. There will be NO REFUNDS after May 22, 2014. However, if you are unable to attend, the seminar material will be provided to you (either by postal mail or email) without additional charge.
  8. Should a seminar be cancelled at any time for any reason, the sole liability of PharmaSUG and the instructor is a refund of the seminar fee, and they are NOT liable for any special or consequential damages arising from the cancellation of the seminar.
  9. On-site registration will be permitted based on space and availability, and payable by major credit card (MC, VISA, Discover, AMEX). However, seminar materials may not be available on-site but will be provided later to paid attendees.
  10. You may sign up for seminars occurring at the same time, i.e., you can attend one class and ask for material for another class, bearing in mind that tuition must be paid for both seminars.

For questions about the above seminar policy and availability, please contact Sandra Minjoe and Richann Watson, Seminar Coordinators, at This email address is being protected from spambots. You need JavaScript enabled to view it..

Course Descriptions

The SDTMIG: Beyond the Modeled Domains and Other Implementation Challenges
Fred Wood, Jerry Salyers
Saturday, May 31, 2014, 8:00 AM - 12:00 PM

This course will cover aspects of the SDTMIG that, in our experience, frequently present the greatest challenges to sponsors. These include the use of variables in the SDTM but not in domain models, when to create custom domains, and when to use Findings About rather than a custom Findings domain. In addition, considerations around when to create Supplemental Qualifiers and how to relate them back to parent domains via the most efficient IDVAR values will be presented. Other, less commonly seen but still problematic challenges include the use of Timing variables and date/time precision, the submission of legacy terms in addition to CDISC Controlled Terminology, misuse of variables, not following conventions established for modeled domains when creating custom domains, and the creation of Trial Design datasets. The course will include exercises 1) to generate discussion, and 2) so that attendees can assess their understanding of the course material. The exercises will not require the use of computers or the knowledge of SAS.

PROC SQL Programming: The Basics and Beyond
Kirk Paul Lafler
Saturday, May 31, 2014, 8:00 AM - 12:00 PM

This course teaches SAS users core concepts and features about accessing data stored in relational database tables. Attendees learn how to use PROC SQL to access data stored in relational tables; accomplish essential programming tasks including retrieving, subsetting, ordering, and grouping data; construct logic scenarios with case expressions; construct “virtual” tables known as views; explore one-to-one, one-to-many, many-to-one, and many-to-many data relationships; understand the similarities and differences between DATA step merges and joins; create complex queries using inner and outer join constructs as well as with set operators; use summary (statistical) functions to aggregate data; create new tables; produce “quality” looking output using PROC SQL options and Output Delivery System (ODS); interface PROC SQL with the macro facility to create single-value and multi-value (list) macro variables; understand basic index rules and strategies; and apply “select” query performance tuning techniques.

CDISC and XML for SAS® Programmers
Lex Jansen
Saturday, May 31, 2014, 1:00 PM - 5:00 PM

Extensible Markup Language (XML) is a markup language that defines a set of rules for encoding documents in a format that is both human-readable and machine-readable. It is an open standard that was developed by the Worldwide Web Consortium (W3C) in order to provide a flexible way to create common information formats and share both the format and the data on the World Wide Web, intranets, and elsewhere. CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC XML Technologies Team creates publishes several CDISC standards in an XML representation. These XML standards include: • Operational Data Model (ODM) • Define-XML • Controlled Terminology in XML (CT-XML) • StudyDataSet-XML. SAS® includes a number of useful generic tools for working with XML. These include: • The XML libname engine – Reading and writing XML documents, optionally with an XML Map. • The SAS XML Mapper – A Java-based, stand-alone application that analyzes the structure of an XML document or an XML schema and generates basic XML syntax for the XML Map. • The Output Delivery System - ODS MARKUP can use a TAGSET to create XML documents. Furthermore, the SAS® Clinical Standards Toolkit is the platform used by SAS® to support Health and Life Sciences industry data model standards. It supports working with several XML based CDISC standards, such as ODM, Define-XML and CT-XML. SAS Clinical Standards Toolkit is under active development with continued releases planned in its product roadmap. This seminar will introduce XML and give examples of the way SAS supports XML, specifically in the context of CDISC. A goal of the seminar will be to gain a better technical understanding of CDISC based XML standards and what the ways are in SAS to efficiently support those XML standards.

How to Leverage the Power of SAS® Enterprise Guide
Scott Leslie
Saturday, May 31, 2014, 1:00 PM - 5:00 PM

SAS® Enterprise Guide® is described as “an easy-to-use interface” that allows users “to access the power of SAS data access, reporting and analytics, enabling you to quickly create and publish SAS Stored Processes that can be leveraged from Microsoft Office applications or Web browsers.” This training session will demonstrate how to leverage the power of SAS while using the handy features of Enterprise Guide to perform jobs quickly and easily. Topics covered include: navigating the Enterprise Guide menus, creating process flows, conducting statistical analyses, creating a report with the Report Builder wizard, combining reports and tasks into a single document using Report layout, and using prompts to generate custom reports from a template. It is intended for SAS programmers with less experience with Enterprise Guide or those that would like to learn handy tips on automating code and processes for a project. The many features of Enterprise Guide versions 4.3 and 5.1 are described and attendees will be able to work with hands-on examples.

How (and Why) to Harmonize Data Collection with CDISC Submission Standards
Steve Kirby, Mario Widel
Sunday, June 1, 2014, 8:00 AM - 12:00 PM

The FDA strongly encourages sponsors to provide study tabulations data in CDISC SDTM format and analysis data in CDISC ADaM format. Planning to provide CDISC data as you translate the protocol into electronic CRF forms and associated output data sets saves money and avoids stress by providing a clear path from collection data to submission domains. As noted by the FDA in recent draft guidance: “Some sponsors choose to convert non-standardized data to a standardized format. In general, we discourage this conversion approach unless it is the only option.” This half-day course will briefly explain the submission process and share how to create a traceable path from collection data to submission domains that is driven by communication and collaboration between groups. Strategies to keep your data processes current as CDISC standards and regulatory expectations evolve through initiatives such as CFAST and the FDA/PhUSE working groups will be discussed. Attendees are expected to be familiar with CDISC data standards and have spent some quality time with protocols and CRFs.

Cleaning, Validating, and Reshaping Your Data: Taking Advantage of SAS Tools
Art Carpenter
Sunday, June 1, 2014, 8:00 AM - 12:00 PM

The procedures of SAS along with the DATA step provide the programmer and data analyst access to flexible programming power unavailable in any other programming language. Along with that power comes the complexity of multiple solutions to many common programming tasks. This class covers a number of Intermediate and Advanced SAS programming topics that offer solutions that take advantage of techniques that are not employed by a majority of SAS programmers. Based on Art’s latest book, Carpenter’s Guide to Innovative SAS Techniques, published in the spring of 2012, this course will extend the knowledge and tool set of SAS programmers that work with data. During this seminar we will: • Learn to create user defined formats and functions to clean and validate your data • Extend PROC COMPARE with the Macro Language to automate data comparisons • Explore alternative techniques to PROC TRANSPOSE when reshaping your data • Discover how to display and report on all levels of classification variables, even when they are not in the data

Survival Analysis
Arthur Li
Sunday, June 1, 2014, 8:00 AM - 12:00 PM

Survival analysis is a common type of analysis that is not restricted in the health care industry but is also applied in other fields. This course will start with exploratory data analysis, such as plotting survival curves from PROC LIFETEST. Then the majority of the course will focus on analyzing survival data by using the Cox proportional hazards model (PROC PHREG). Related topics include validating model assumptions and assessing the fit of the model. New statements in PROC LIFETEST and PROC PHREG that are new to SAS 9.2 and ODS statistical graphics relating to survival analysis will also be presented. PRE-REQUISITE: Basic knowledge of SAS programming (such as creating SAS data sets and variables by using the DATA step) and basic knowledge of simple linear regression.

FDA Submission Data Requirements
Dave Izard
Sunday, June 1, 2014, 1:00 PM - 5:00 PM

SAS statistical and programming professionals work tirelessly contributing to CRF & clinical database design, protocol & SAP development, analysis dataset design & implementation and the generation of tables, figures and listings in support of clinical trials. If the compound under study successfully navigates clinical and regulatory hurdles, most of these items will make their way into a regulatory submission to the FDA. There are many sources of information on how to organize and present these assets to the FDA for their consideration, many of which seemingly contradict each other, making the requirements for regulatory submission cloudy at best. This highly interactive seminar will review each asset, its role in the submission and the various standards and guidance documents that affect how that asset is handled as it weaves its way through the drug development lifecycle on its way to the FDA. A portion of the seminar will be dedicated to a discussion of “hot off the press” topics, including assessing the impact of recent changes to standards and guidance documents as well as FDA submission feedback. Audience Level Beginner to Intermediate – individuals who are new to the Pharmaceutical industry would benefit greatly for the opportunity to put their hard work creating analysis datasets and TLFs into the context of a regulatory submission. Conversely, experienced professionals who have created submission assets in the past who are looking for a refresher on recent changes to FDA requirements, CDISC standards and the future European outlook on submission data requirements would also enjoy this seminar.

Getting Started with Graph Template Language
Sanjay Matange
Sunday, June 1, 2014, 1:00 PM - 5:00 PM

With SAS 9.2 Graph Template Language (GTL), you can create complex graphs frequently used in many industries including Health and Life Sciences, Insurance, Finance and more. This half-day course will cover the key features of GTL using examples from the above industries, including graphs commonly used for analysis of safety data for clinical trials. We will build graphs such as the Forest Plot, LFT Patient Profiles, Adverse Event Timelines, Survival Plot, Most Frequent AE and more using the GTL. Course outline: • Brief overview of ODS Graphics. • Review of key GTL features. • Single cell graphs. • Multi-cell graphs. • Customizing SAS procedure templates. • Review of key SAS 9.3 features. • Using ODS Graphics Designer for fast graph prototyping.

ADaM Datasets: Creation and Applications
Nancy Brucken, Mario Widel, Paul Slagle
Wednesday, June 4, 2014, 1:00 PM - 5:00 PM

This half-day course shows you how to develop your CDISC ADaM datasets to enable your specific statistical analyses, such as t-tests, proportions, time to event, adverse events and ANOVA. Students will learn specifics of the published ADaM dataset structures and how to apply them to their own clinical study data. Additionally, we will examine situations that don’t fit the published structures like concomitant medications and multivariate analyses and describe options for handling them.

Building Dynamic Programs and Applications Using the SAS Macro Language
Art Carpenter
Wednesday, June 4, 2014, 1:00 PM - 5:00 PM

This seminar shows you how to take advantage of SAS Macro Language capabilities that enable you to write dynamic programs and applications. By mastering the concepts and techniques presented in this class your programs will become free of hard-coded data dependencies, thus eliminating the need to re-write the code every time a data set name, variable name, or other data attribute, changes. Let “them” change the project's specifications as often as “they” want...your code is ready! The dynamic programming techniques that you will learn about during this seminar: - Are flexible and are easily adaptable to changing data structures, data table names, and variable (field) attributes - Reduce maintenance requirements by removing data dependencies from within the programs - Provide significant resource savings during program/application development cycles - Gives the end-user extensive control over program execution by using tables such as SAS data dictionaries, SAS data sets, and Excel tables - Reduce program validation efforts by providing reusable and generalized code that can be applied to many different applications - Establish controlled data environments, thus insuring data integrity throughout your organization This course makes extensive use of example macros that have been gathered from real world applications, and it concentrates on the techniques necessary to make effective use of these tools.

Advanced Reporting and Analysis Techniques for the SAS® Power User: It's Not Just About the PROCs!
Art Carpenter
Thursday, June 5, 2014, 8:00 AM - 5:00 PM

There are literally hundreds of techniques used on a daily basis by the users of SAS® software as they perform analyses and generate reports. Although often obscure, most of these techniques are relatively easy to learn and generally do not require specialized training before they can be implemented. Unfortunately a majority of these techniques are used by only a very small minority of the analysts and programmers. They are not used more frequently, because a majority of SAS users have simply not been exposed to them. Left to ourselves it is often very difficult to ‘discover’ the intricacies of these techniques and then to sift through them for the nuggets that have immediate value. This one day course presents a series of those nuggets. It covers a broad range of SAS topics that have proven to be useful to the intermediate and advanced SAS programmer who is involved with the analysis and reporting of data. The intended audience is expected to have a firm grounding in Base SAS. For most of the covered topics, the course will introduce useful techniques and options, but will not ‘teach the procedure’. No matter how experienced we are, no matter how well we know a procedure or a technique, there is still more that we do not yet know. The course includes options and techniques associated with: New, powerful, and little used options in MEANS/SUMMARY Reporting procedures including TABLULATE and REPORT Understanding more about the REPORT compute block In the DATA step (functions, options, statements) Working with data Taking full advantage of formats Interfacing with the Macro Language Output Delivery System, ODS, extras Operating System Interfaces and how you can take advantage of them Advanced Table look-up techniques Importing and exporting data . . . . much, much more Students attending this seminar will be exposed to a broad range of techniques, procedures, options, and statements. Throughout the seminar the discussion will include comparisons of coding and operating efficiencies. Even the most advanced students will come away from the training with a broader appreciation for the SAS System, its depth and its flexibility, and the programmer’s ability to tap into those capabilities.

Instructor Biographies

Nancy Brucken

Nancy Brucken has been a statistical programmer in the pharmaceutical industry for over 20 years, on both the pharmaceutical company and CRO sides, and a member of the ADaM Occurrence Structure sub-team for the past 2 years. She is a frequent presenter at local and regional SAS conferences, a proud graduate of Marietta College, and a devout Ohio State Buckeyes fan.

Art Carpenter

Art Carpenter’s publications list includes five books, and numerous papers presented at SAS Global Forum, and other user group conferences. Art has been using SAS® since 1977 and is a SAS Certified Advanced Professional Programmer. Through California Occidental Consultants he teaches SAS courses and provides contract SAS programming support nationwide.

David Izard

Dave Izard frequently finds himself at the intersection of clinical data standards, regulatory expectations and sponsor organization needs and desires. A SAS user since 1994 and pharmaceutical professional since 1997, he current serves as the Head of Clinical Product Strategy & Development for Accenture’s Accelerated Research & Development Shared Services after leading Octagon Research Solutions / Accenture’s SDTM practice for 6 years. Prior to joining Octagon / Accenture he served in a variety of Clinical Programming leadership roles at both GSK and Shire. He has been participating at PharmaSUG since 1990, supporting the conference as a presenter / seminar instructor as well serving in a number of leadership roles. He holds Bachelors and Masters of Science Degrees in Computer Science from Bucknell and West Chester University respectively.

Lex Jansen

Lex Jansen is a Principal Software Developer at SAS Institute, Health and Life sciences R&D. In this role he develops software that supports data standards in the pharmaceutical industry. Currently he is one of the developers working on the SAS Clinical Standards Toolkit. Prior to working at SAS he was a Senior Consultant, Clinical Data Strategies at Octagon Research Solutions, Inc. In this position Lex worked on client consulting projects dealing with the assessment, design and/or implementation of CDISC standards. Previous to his employment with Octagon, he held various positions in the 16 years that he worked at the pharmaceutical company Organon. Lex holds a MSc in Mathematics from the Eindhoven University of Technology in the Netherlands. Since 2008 Lex has been an active member of the CDISC XML Technologies Team and was one of the developers of the Define-XML 2.0 specification.

Steve Kirby

Steve Kirby, Manager of Data Standards Implementation at Shire, has over a decade of industry experience in clinical and statistical programming. His primary focus is (and for a long time has been) on optimizing the delivery of submission data and documentation that comply with CDISC standards. Steve holds a JD, an MS in Biometry, is a member of the CDISC ADaM team and ADaM PK subteam and is involved with the FDA/CSS working group focused on optimizing the use of data standards.

Kirk Paul Lafler

Kirk Paul Lafler is consultant and founder of Software Intelligence Corporation and has been using SAS since 1979. He is a SAS Certified Professional, provider of IT consulting services, trainer to SAS users around the world, and sasCommunity.org Advisory Board emeritus member. As the author of five books including PROC SQL: The Basics and Beyond Using SAS, Second Edition (SAS Institute. 2013), Kirk has written more than five hundred papers and articles, been an Invited speaker and trainer at four hundred-plus SAS user group conferences and meetings, and is the recipient of 23 “Best” contributed paper, hands-on workshop (HOW), and poster awards. His popular SAS Tips column, “Kirk’s Korner of Quick and Simple Tips,” appears regularly in several SAS User Group newsletters and websites, and his fun-filled SASword Puzzles are featured in sasCommunity.org.

Scott Leslie

R. Scott Leslie is a Health Outcomes Researcher for MedImpact Healthcare Systems, Inc. with 15 years of SAS® experience in the pharmacy benefits and medical management field. His SAS skills include Base SAS, SAS/STAT, SQL, Enterprise Guide, and ODS. Scott holds a Masters of Public Health degree in Epidemiology and Biostatistics from Loma Linda University. He is an author of a SAS book chapter and has presented at local, regional and international SAS user group