SAS Training Outline:

This training is focused on educating SAS consultants in Pharmaceutical or Contract Research Organization (CRO) company. Each session in this training will be followed by solving examples and summarizing contents covered. At the end of each day, trainees will be given actual Pharmaceutical data and exercise to work on as homework. There assignments will be evaluated weekly and graded for their improvement and perfection. Some of the sessions will include power point presentation and will need consultants to use SAS interactively. Printed notes will be shared on some topics. At the mid and end of training, consultants will be given project that they will have to finish within the given timeline. The final session will include 2hrs workshop on writing and developing their Resumes. Finally mock interviews will be conducted individually for each consultant. Note: Time included in each session includes examples and problem solving.

Session 1: Introduction to Basic Functionality and Programming Concepts in SAS

Time: 8hrs Session Contents
Introducing the Course Scenarios

Defining the course scenario Defining the lecture scenario

Getting Started with SAS

Understanding basic programming conventions Overview of the SAS system and types of SAS products used with different operating environment in Pharmaceutical Industry Introduction to SAS programs (Components, Characteristics, Layout, and Processing of SAS Programs) Exploring SAS Windowing Environment o identifying the three primary SAS programming windows o navigating SAS programming windows o editing and executing SAS code o saving and retrieving SAS code o using the SAS Help facility Diagnosing SAS programs, log messages, and results of processing

Getting Familiar with SAS Library and SAS Data Sets

Explaining the concept of a SAS data library o How SAS files are stored o Creating temporary or permanent libraries Understanding SAS data sets o Overview of data sets o Data types and size of SAS data sets

o Observations (Rows) and Variables (Columns) o Missing values

Rules for SAS names Methods for getting data into SAS Reading raw data (text, ASCII, CSV, Excel and flat files) into SAS and converting it to SAS dataset

Session 2: Using SAS DATA steps

Time: 12hrs Session Contents
Programming with the DATA Step

Creating SAS data set using DATA steps Creating and Modifying variables Associating and changing SAS variable attributes Executing statements conditionally (If-then-else) Dropping and Keeping variables in a dataset Understanding DATA step processing

Combining SAS Data Sets

Concatenating SAS data sets Merging and Interleaving SAS data sets Combining SAS data sets using additional features Excluding and Selecting variables from a dataset

Working with SAS Data

Using and Selecting SAS functions (PUT, INPUT, MIN, MAX, SUM, UPCASE, etc.) Working with SAS formats and informats Understanding SAS dates

Session 3: Getting Acquainted with SAS PROCEDURES

Time: 12hrs Session Contents
Producing Listing and Summarizing data by using Procedures in SAS

Using SAS procedures Getting started with the PROC PRINT Sorting and Grouping observations using PROC SORT Creating user defined formats using PROC FORMAT Summarizing data using PROC MEANS Counting data with PROC FREQ Producing table using PROC TABULATE and PROC REPORT

Transposing data with PROC TRANSPOSE Subsetting in Procedures using WHERE statement

Session 4: Output Delivery System (ODS)

Time: 6hrs Session Contents
Enhancing your output with Output Delivery System (ODS)

Concepts of Output Delivery System and its usefulness in generating SAS outputs Select and trace procedure output for selective listings Using ODS to create HTML, PDF, RTF and PRINTER output Customizing ODS output using STYLE and PROC TEMPLATE option Generate summary tables using ODS RTF and PROC REPORT

Session 5: Using SAS Macro Facility

Time: 8hrs Session Contents
Conceptual understanding and learning of SAS Macro facility

Macro concepts Substituting Text with Macro variables Adding different parameters to Macros What are the advantages of the SAS Macro facility Writing data driven programs with CALL SYMPUT Understanding automatic and user-defined macro variables

Session 6: Introduction to Drug Development Process in Pharmaceutical Industry

Time: 8hrs Session Contents
Introduction to drug discovery and development process

Overview of highly regulated drug development process, from discovery to bringing a biopharmaceutical product to market Understanding major phases (Phase I IV) of clinical trials and clinical data management Learning rationale for each phases of drug development cycle and introducing role of SAS programmer in each phase. Food and Drug Administration (FDA) regulations and Guidance (21 CFR part 11, GCP, eCTD) Regulatory overview and approval process including IND/NDA to FDA

Role of SAS programmer at any biotech/pharmaceuticals/CRO industry in FDA application Types and parameters of Clinical trials

Getting in depth knowledge about the functional group and working of CRO/Pharmaceutical industry and knowing in and out of guidelines pertaining to company involved in clinical trials

Learning about the general department structure of pharmaceutical industry, roles and responsibilities of SAS programmer in the company Getting to know what Standard Operating Procedures (SOPs) and Guidelines are and its importance Discussing and Reviewing sample SOPs and Guidelines from a real pharmaceutical industry Understanding clinical study and documents {e.g. Protocols, Case Report Form (CRF), annotated and electronic Case Report Form (aCRF and eCRF), Statistical Analysis Plan (SAP)} Get a feel of folder structure adopted by most of the pharmaceutical and CRO companies Learning more about types of analysis in clinical trials (Pharmacokinetic, Pharmacodynamics, Efficacy, Safety, etc.)

Session 7: Introduction to Clinical Trial Data

Time: 8hrs Session Contents
Clinical data preparation issues and different class of clinical data found in clinical trials

Learn to prepare and clean clinical trial data Know how to categorize and summarize clinical data Studying and classifying different types of clinical trial data {Safety (ISS) and Efficacy (ISE) Data} Getting acquainted with new Clinical Data Interchange Standards Consortium (CDISC) implementation in categorizing clinical data Working with real pharmaceutical industry data (demographics, concomitant medication, medical history, laboratory data, adverse event, end point data, etc.)

Session 8: Using SAS to Create Analysis Data sets

Time: 3hrs Session Contents
Learning tips and tricks to create and manage analysis data sets

Key concepts for creating and transforming analysis data sets (Using DATA steps and PROC TRANSPOSE) Comparing Data sets using PROC COMPARE Learning about use of Medical Dictionaries (MedDRA and WHO Drug) in generating Adverse Event dataset Understanding and creating Time-to-Event, Change-from-Baseline, Critical variables data sets

Session 9: Generate Customized Clinical Trials Tables, Listings and Graphs/Figures

Time: 5hrs Session Contents
Creating Tables and Listings

Using PROC TABULATE to create clinical trial tables Using PROC REPORT to report clinical trials tables and listing Creating summaries of Adverse Event, Concomitant medication, Laboratory data using DATA steps and various SAS Procedures Creating Kaplan-Meier Survival Tables using PROC LIFETEST or PROC GPLOT Using ODS with PROC REPORT and PROC TABULATE to generate nice looking tables and listings

Generating Graphs and Plots using SAS/BASE, SAS STAT and SAS/GRAPH

Producing Bar and Pie charts using PROC GPLOT and PROC GCHART Creating Box and Scatter Plot using PROC BOXPLOT, PROC GPLOT and PROC UNIVARIATE Creating Kaplan-Meier Plot using PROC GPLOT or PROC LIFETEST

Session 10: Resume Workshop

Time: 2hrs Session Contents
Consultants will have opportunity to write and develop there resumes in this workshop. Sample resumes from experience SAS Consultants will be shared. They will be instructed on skills sets that must be listed on there resumes. Every consultants resume will be reviewed by me personally before sending it out for marketing purpose.

Session 11: Mock Interview

Time: 30mins each consultant Session Contents
Consultants will undergo mock interview session when they are ready for marketing and taking up there first client project. This can be conducted on the phone or in person.