PROGRAM - Pharmasug



PharmaSUG 2010 Pre-Post Conference Seminars

Seminar #1:  Saturday May 22, 2010, 8:00 AM – 12:00 PM

TITLE: Introduction to ADaM and ADSL

INSTRUCTOR: Sandra Minjoe

OVERVIEW: This seminar will cover the CDISC Analysis Data Model (ADaM) v2.1, the ADaM Implementation Guide v1.0, and include hands-on practice of the Subject-level analysis data structure (ADSL).

PRE-REQUISITE:

• Students in this seminar should have an understanding of:

– SDTM structures

– FDA needs

– Clinical data flow

• Students in this seminar do not need SAS programming skills

AUDIENCE/LEVEL: Intermediate

DESCRIPTION:

This seminar begins by introducing attendees to CDISC, ADaM and the ADaM documents. We discuss how ADaM fits into the clinical process, and describe the key principles of ADaM.

The seminar then delves into the specifics of the ADSL model, its data and metadata. Examples and exercises allow attendees to practice and prepare for application at their own company.

Attendees may bring their laptops to do Excel-based exercises. All attendees will receive a thumb drive with course materials plus other handouts.

BENEFITS OF TAKING THIS SEMINAR:

At the end of this seminar, students will be able to:

• Find current CDISC standards

• Understand the need for ADaM

• Create ADaM ADSL data and metadata

Seminar #2:  Saturday May 22, 2010, 8:00 AM – 12:00 PM

TITLE: Introduction to Enterprise Guide 4.2

INSTRUCTOR: Ben Cochran

OVERVIEW: This course will show student how to do many SAS tasks, such as joining data, generating reports, etc., in Enterprise Guide. Many users see Enterprise Guide as another SAS tool to get the job done…usually more quickly than using other methods.

PRE-REQUISITE: NONE

AUDIENCE/LEVEL: Any level of SAS user

DESCRIPTION:

This is a half day course that will get the user up and running with the point and click interface of Enterprise Guide. This course will use release 4.2 of Enterprise Guide.

BENEFITS OF TAKING THIS SEMINAR:

Students who take this course will learn about the SAS System in general and especially Enterprise Guide. This understanding will help the student to write more efficient programs as well as utilize more features of the SAS System through the point and click interface of Enterprise Guide. Many students who know how to use Enterprise Guide

find that they can do SAS things more quickly with this product; whether it be manipulating data or generating reports.

Seminar #3:  Saturday May 22, 2010, 8:00 AM – 12:00 PM

TITLE: Moving to Release 9.2 of SAS/GRAPH® Software

INSTRUCTOR: Mike Kalt

OVERVIEW: Release 9.2 of SAS/GRAPH contains a number of new procedures and features that make it much easier to produce statistical graphics than in previous releases of the product. This seminar will provide an overview of the changes and new features and show you how to create commonly-used statistical graphs with a minimum of effort.

PRE-REQUISITE: Experience using SAS/GRAPH software

AUDIENCE/LEVEL: Anyone with a basic knowledge of SAS who needs to produce statistical graphics

DESCRIPTION:

Release 9.2 of SAS/GRAPH Software provides a number of new features and changes of interest to those producing statistical graphics. These include:

• Changes in the default appearance of graphs, and more integration with ODS

• New procedures, such as GTILE and GKPI that produce tile charts and KPI charts.

• A new set of procedures (SCGPLOT, SGPANEL, SGSCATTER, and SGRENDER) that more easily produce commonly used-statistical graphs than procedures such as GPLOT and GCHART.

The seminar will show you how to take advantage of the new features to more easily create statistical graphs in formats suitable for publication. You will also learn how to make sure that output from any existing graphics applications does not change in appearance when you move to Release 9.2.

BENEFITS OF TAKING THIS SEMINAR:

After taking the seminar you will be able to:

• Use ODS to format your graphs and combine them with tables to produce output suitable for publication in a number of formats.

• Modify existing SAS/GRAPH applications to take advantage of new features or ensure that they maintain the same appearance as in previous releases.

• Use SAS/GRAPH to easily produce common statistical graphics such as box plots, histograms, dot plots, density plots, and regression plots.

Seminar #4:  Saturday May 22, 2010, 1:00 PM – 05:00 PM

TITLE: Applications in Creating ADaM Datasets

INSTRUCTOR: Mario Widel

OVERVIEW: This seminar continues covering the Analysis Data Model (ADaM) v2.1 and the ADaM Implementation Guide v1.0 from the “Introduction to ADaM and ADSL” seminar. It includes hands-on practice of safety and efficacy analyses using ADaM data structures.

PRE-REQUISITE:

• “Introduction to ADaM and ADSL” seminar or equivalent experience

• Students in this seminar should also have an understanding of:

– SDTM structures

– FDA needs

– Clinical data flow

• Students in this seminar do not need SAS programming skills

AUDIENCE/LEVEL: Intermediate

DESCRIPTION:

This seminar introduces attendees to the different ADaM structures, data and metadata. It focuses on the specifics of the BDS model.

Examples and exercises allow attendees to practice and prepare for application at their own company. These include both safety and efficacy analyses in the form of lab change from baseline, shift table, survival and time-to-event.

Attendees may bring their laptops to do Excel-based exercises. All attendees will receive a thumb drive with course materials plus other handouts.

BENEFITS OF TAKING THIS SEMINAR:

At the end of this seminar, students will be able to:

• Understand the different ADaM structures

• Create ADaM BDS data and metadata

Seminar #5: Saturday May 22, 2010, 1:00 PM – 05:00 PM

TITLE: Manipulating Data with SAS Functions

INSTRUCTOR: Ben Cochran

OVERVIEW: This half day workshop explores the area of data manipulation and shows you how to accomplish this through using the myriad of functions provided by the SAS® System. This course includes some new SAS9 functions

PRE-REQUISITE: Familiarity with the DATA step.

AUDIENCE/LEVEL: Any level SAS user.

DESCRIPTION:

This course really goes into a lot of detail on Numeric, Character, and other types of functions available in SAS. This course not only introduces the user to these functions, but shows how to use these functions in the DATA step and other areas of SAS.

BENEFITS OF TAKING THIS SEMINAR:

Many programming tasks involve manipulating data. By taking this course, the student will learn a lot about how to do this with SAS.

Seminar #6: Saturday May 22, 2010, 1:00 PM – 05:00 PM

TITLE: Using Dictionary Tables in Pharmaceutical Applications

INSTRUCTOR: Frank DiIorio

OVERVIEW: This seminar introduces attendees to SAS Dictionary Tables. It describes the structure and content of the Tables that are most applicable to pharmaceutical applications, then presents a series macro-based examples. These examples and other Table-based utilities will be available on the instructor’s web site.

PRE-REQUISITE: Basic knowledge of SQL and macro language

AUDIENCE/LEVEL: Beginner/Intermediate statistical/data management programmers

DESCRIPTION:

SDTM, ADaM and a host of other emerging standards have added complexity to the already challenging life of pharmaceutical industry programmers. These standards are typically represented as metadata that describe the attributes of deliverables such as datasets and displays.

SAS dictionary tables are another, complementary metadata source. These tables contain a wealth of information about a SAS session, describing contents of datasets and views, identifying macro variables, titles and footnotes, ODS destinations, and characteristics of external files. The tables are useful in and of themselves (think “utility macros”). And they become even more valuable to programmers who must ensure deliverables’ compliance with standards.

This seminar takes attendees on a tour of the more commonly used dictionary tables. It:

• Presents an overview of how the tables are created and maintained

• Illustrates the relationships among the tables

• Demonstrates different ways to view the tables’ contents

• Identifies usage quirks and “features”

• Gives examples of how they can be used for both generalized and pharma-specific applications

BENEFITS OF TAKING THIS SEMINAR:

Provide knowledge of the structure and capabilities of Dictionary Tables. Learn how to use them to develop generalized programs that are more robust and efficient than their “Table-less” counterparts.

Seminar # 7:  Sunday May 23, 2010, 8:00 AM – 12:00 PM

TITLE: Introduction to Lean Six Sigma in Health and Life Sciences

INSTRUCTOR: Gregory S. Nelson

OVERVIEW:

In order to remain competitive, cost efficient, and up-to-date, Healthcare and BioPharma organizations must employ continuous and systematic innovation efforts. This workshop will prepare you to begin your journey in Lean Thinking and Six Sigma and will illustrate how these can be applied in healthcare, research and operations. Controlling cost increases, improving quality, and providing better health outcomes are some of the benefits of this approach and begins your next step in your professional journey joining hundreds of thousands of people who have taken Lean and Six Sigma into their careers.

This workshop illustrates how Lean thinking – through its original concepts, to its initial impact on manufacturing, and now to delivery of healthcare and clinical research – can dramatically affect quality of service. Lean implies developing value through the identification of process problems and the elimination of waste by creating value streams that identify unnecessary complexity and time-intensive processes. Additionally, many other Lean tools can contribute to delighted customers – internal or external and improved organizational efficiency. Several case studies will be discussed in this program taken from statistical programming, health plan operations and clinical research.

PRE-REQUISITE: NONE

AUDIENCE/LEVEL: Course objectives for this program specifically target SAS programmers, statisticians and managers in BioPharma and Healthcare companies.

DESCRIPTION:

This overview course is designed to provide a broad understanding of the Lean and Six Sigma improvement methodology, concepts, and language. The Define-Measure-Analyze-Improve-Control methodology is presented with case studies and examples drawn from health plans, pharmaceutical, academic medical centers and broad research analytic applications. With a heavy practice orientation, as much as a third of your time will be spent working through interactive practice exercises that highlight the practical side of Lean and how it can be quickly applied in your organization.

This course is a workshop based learning experience, with lecture, classroom discussion, quizzes, glossary, and exercises. All course content is included with the workshop handouts.

BENEFITS OF TAKING THIS SEMINAR:

By the end of this program, the workshop participant should be able to:

• Evaluate Lean methods as applied in healthcare and BioPharma organizations to include why and how they work.

• Understand the benefits and implications of a Six Sigma program, and relate Six Sigma concepts to the overall business and/or departmental mission and objectives

• Relate your own organizations as a collection of processes, with inputs that determine the output

• Describe Lean Thinking and Six Sigma and its role in creating challenging environments to engage people to think and grow in their work.

• Recognize how Lean methods build quality into any process by eliminating waste.

• Define the importance and role of value stream mapping.

• Use Lean six sigma techniques to form the basis for ongoing continuous improvement.

• Use the concept of a Sigma Level to evaluate the capability of a process or organization

• Recognize the five-step D-M-A-I-C model used to improve processes

• Recognize the organizational factors that are necessary groundwork for a successful Six Sigma program

• Integrate a Six Sigma effort with other process improvement initiatives.

• Understand how SAS can be used to support the analysis of information collected as part of the DMAIC process.

SEMINAR #8 – Sunday May 23, 2010, 8:00 AM – 12:00 PM

TITLE: Introduction to the Output Delivery System: From the Basics to Practical Application

INSTRUCTOR: Art Carpenter

OVERVIEW: This introduction to the Output Delivery System will get you started and well on your way to using ODS as a integral part of your reporting.

PRE-REQUISITE: SAS Basics or similar course

AUDIENCE/LEVEL: Beginner to early intermediate

DESCRIPTION:

Since its introduction in Version 7, the Output Delivery System, ODS, has significantly altered how we utilize and view output generated by SAS procedures. We now have the ability to route our output to a variety of file types, we can capture output as data, and we can control fonts, colors, and destinations. ODS gives the programmer vast powers of control. All we need to do is step up and take that control.

This course introduces ODS and shows the programmer how to take advantage of its many capabilities. The course concentrates on the many options and features of the ODS statement, but also covers related topics that make use of ODS capabilities

ODS is here to stay and as its features become even more embedded within the SAS System, it will be even more important for you to know how to make it work for you. Join us. Learn ODS now. Learn to:

write reports in HTML, RTF, and PDF

create data sets from reports

control procedure output, what it looks like, and what it contains

create linked documents

use the fundamentals of traffic lighting

. . . . and much more

BENEFITS OF TAKING THIS SEMINAR:

You will be able to immediately start using the Output Delivery System to create the attributes of the reports that your boss wants to see.

SEMINAR #9 – Sunday May 23, 2010, 01:00 PM – 05:00 PM

TITLE: An Introduction to the SAS Clinical Standards Toolkit

INSTRUCTOR: Tim Thompson and Chris Decker

OVERVIEW: This seminar provides an overview of the SAS Clinical Standards Toolkit (CST). There is a brief overview of installation, a discussion of content and organization of CST, getting started with your first study, and strategies for running CST.

PRE-REQUISITE: Experience with Base SAS programming and SAS macro language.

AUDIENCE/LEVEL: statistical programmers and data managers / intermediate to advanced

DESCRIPTION:

1. CST: What is it and what does it do?

a. SDTM Standards and Checks

b. CRTDDS Standards and Checks

c. Creation of define.xml files

2. Installation

a. 9.1.3 versus 9.2

b. Where to get the install package

c. Ant

d. Troubleshooting

3. How CST is Organized

a. CST Framework

b. Global Library

c. Samples

4. A Simple Example of Running a Study Through SDTM Checks

a. Create metadata tables for study tables and columns

b. Create a table of SDTM checks to run

c. Create a references table that defines librefs/filerefs for your study

d. Create a program to call SDTM macros

e. Review the output

5. Running SDTM Checks: Digging into the Details

a. The structure of the metadata tables: basic columns versus extended columns

b. A strategy for creating metadata tables

c. SDTM Checks: what is available

d. The sasreferences table: linking the pieces

e. The processing program: making something happen

f. Interpreting the output

g. Some utility macros supplied by CST

h. Some tools you can build

6. A Simple Example of Converting SDTM Metadata to CRT-DDS Metadata

a. Metadata tables for the study, the tables and columns

b. The sasreferences table: linking the pieces

c. The processing program: making something happen

d. The metadata tables for CRT-DDS

7. A Simple Example of Creating a define.xml file

a. Metadata tables for CRT-DDS representation

b. The sasreferences table: linking the pieces

c. The processing program: making something happen

8. Building Your Own Standards

a. What pieces do you need?

b. How do you organize it

c. Registering Standards to CST

d. Using your Standards

9. Other Components of CST

a. A Quick Review of Utility Macros

b. CST Properties and Macro Variables

10. Final Thoughts

a. Example of how to quickly push lots of studies through CST

b. The good , the not so good

BENEFITS OF TAKING THIS SEMINAR:

After completion of this seminar, you should

• understand the capabilities of the SAS Clinical Standards Toolkit

• be able to troubleshoot installation issues

• understand how to set up your first study set up to run with SAS Clinical Standards Toolkit

• understand the checks that are available and the output that is generated

• know how to use Toolkit utility macros and how to create your own macros to automate the preparation of data metadata

SEMINAR #10 – Sunday May 23, 2010, 01:00 PM – 05:00 PM

TITLE: SAS and XML

INSTRUCTOR: Cynthia Zender

OVERVIEW: Everybody is talking about XML and you want to know what all the buzz is about. And, you want to know what it means for you. Perhaps your company sends XML files that represent account or loan information to auditors in XML format or maybe you’ve heard your company's web team talk about delivering web pages as XML. And now, you want to know more about XML and in particular, SAS and XML.

PRE-REQUISITE: Understand basic SAS programming, use of LIBNAME statement, basic procedure invocation, and ODS basic concepts. Knowledge of XML concepts helpful but not required.

AUDIENCE/LEVEL: Intermediate level SAS programmers

DESCRIPTION: This seminar provides examples of how XML is used in the “real world”. Several methods of creating XML files with SAS will be covered, including how to create an XML file from a SAS dataset using the SAS XML Libname engine and how to create an XML file from SAS Procedure output using ODS and the default XML tagset template. In addition, 2 separate examples of creating custom tagset templates will be covered. One example will generate a custom tagset template for use with the SAS XML Libname Engine. The second example will create an XML file from PROC FREQ and then use a custom tagset template and an XSL file to transform the file from XML to HTML. A third example shows the use of ODS to create an XML file in a specific format. (Note that although CDISC XML will be discussed in general, specific CDISC topics and use of the CDISC Toolkit from SAS will NOT be covered in this seminar.)

BENEFITS OF TAKING THIS SEMINAR:

Learn basic XML concepts; understand what you can and can't do with ODS Tagset templates; understand the difference between XML files created with the SAS XML Libname Engine and ODS Tagset templates.

SEMINAR #11 – Wednesday May 26, 2010, 01:30 PM – 05:30 PM

TITLE: Leadership 101: What Everyone Should Know About Managing SAS Programmers

INSTRUCTOR: Gregory S. Nelson

OVERVIEW: What Everyone Should Know About Managing SAS Programmers and becoming a leader

PRE-REQUISITE: Interest in skills for managing programmers

AUDIENCE/LEVEL: IT, technical and business professionals, including team leaders, managers, directors and others who want to enhance their leadership skills.

DESCRIPTION:

There is a tremendous amount of uncertainty and change in today’s business environment and it is critical to improve yourself by increasing your effectiveness as a leader and ready yourself to meet the difficult challenges in your organization and your career.

While there are a plethora of leadership training seminars, we take a slightly different approach by focusing on the people, processes and organizational characteristics that help us lead. These include:

• • Leading upwards: Understand your role in terms of the organization’s goals, priorities, constraints, culture and measurements and how you can use that information as a leader.

• • Leading laterally: How you can effectively manage people and projects and building working relationships characterized by teamwork and effective collaboration.

• • Leading employees: From hiring the right people to managing poor performance, here, we look at processes for team communication, problem solving, and conflict resolution.

• • Leading yourself: One of the most effective tools that any manager can have is a good handle on how you lead yourself.

BENEFITS OF TAKING THIS SEMINAR:

Learn how to manage SAS programmers

Practice problem solving with real-world exercises

Take away tools that you can use to evaluate your employees and/or team members skills and interests

SEMINAR #12 – Wednesday May 26, 2010, 01:30 PM – 05:30 PM

TITLE: Using SAS/GRAPH® Software in Clinical Trials

INSTRUCTOR: Art Carpenter

OVERVIEW: Using typical graphs generated in the clinical setting, this course introduces the fundamental options, statements, and procedures necessary to get started using SAS/GRAPH.

PRE-REQUISITE: SAS Basics or equivalent course

AUDIENCE/LEVEL: Beginner to early intermediate

DESCRIPTION:

This introductory workshop covers the essentials necessary for getting started with SAS/GRAPH. The workshop assumes no knowledge of SAS/GRAPH and even SAS programmers with minimal experience with the DATA and PROC steps will benefit from the instruction.

While the topics are not specific to clinical trials the topics have been selected specifically to address the fundamental issues encountered by the clinical programmer.

The course includes procedures, options, and techniques that will assist you to:

Set up your graphics environment using specific graphics options

Enhance text including titles, footnotes, legends, and labels

Create Scatter plots and histograms

Create, modify, and control axes and legends

Specify plot symbols, lines, colors, and fill patterns

Combining multiple plots using templates of your own creation

Create plots specifically for publishing to the web or to a word processor

BENEFITS OF TAKING THIS SEMINAR:

It is not as hard as you have heard. Take this course today and you will be using SAS/GRAPH effectively tomorrow.

SEMINAR #13 – Thursday May 27, 2010, 8:00 AM – 05:00 PM

 ****** This is a day long class ******

TITLE: Advanced Reporting and Analysis Techniques Used in the Clinical Setting: It's Not Just about the Procs!!

INSTRUCTOR: Art Carpenter

OVERVIEW: This seminar covers a very wide range of advanced, and often obscure, techniques that users should be taking advantage of on a regular basis. The topics are very eclectic and cover a broad spectrum of different aspects of the SAS system.

PRE-REQUISITE: Training and experience that is “Beyond the Basics”.

AUDIENCE/LEVEL: Students should have a strong intermediate to advanced understanding of basic SAS techniques

DESCRIPTION:

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 hundreds of 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 advantage of formats

Interfacing with the Macro Language

Output Delivery System, ODS, extras

Operating System Interfaces and how you can take advantage of them

Table look-up techniques

Importing and exporting data

. . . . much, much more

BENEFITS OF TAKING THIS SEMINAR:

The techniques covered in this course can not only be put to immediate use, but will also have immediate benefit.

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