Course Details

Transform your SAS Career

Our unconventional learning platform combined with our 24/7 online support and physical guidance provides a learning experience which transforms you through rigorous coursework, by providing an understanding of the needs of society and industry.

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Additional Benefits

Resume Preparation

Interview Preparation

Mock Interview

Real Time Training

100% Hands-on live training

Testing

Tailor made tests and quizzes to meet the current industry requirements

SAS Base

What is SAS

  • Basic overview about SAS software
  • Basics of programming
  • SAS syntax
  • Basic SAS concepts
  • SAS statements
  • SAS syntax rules

SAS dataset

  • SAS libraries accessing
  • Datasets reading
  • SAS data as input
  • Observations & variables
  • Data portions
  • Working with Excel worksheets
  • Importing Excel file

Descriptors

Raw data files

  • Reading of raw data
    Raw data compilation
  • Procedures and techniques for validating and cleaning data

Manipulating data

  • Creating of Variables
  • Sub setting
  • Combining Datasets
  • Merging the SAS dataset

Enhancing Report (ODS systems)

  • Details of Global statements
  • Working with Format & Label Statements
  • User Defined formats
  • Sending output to external files

Summary Reports with FREQ and MEANS Procedure

Controlling Input and Output: Multiple SAS Datasets and Selecting Variables & Observations

Summarizing Data

Reading Raw Data Files

Transpose procedure

Data Transformations

SAS Arrays

SAS & Clinical Module

What is SAS

  • Basic overview about SAS software
  • Basics of programming
  • SAS syntax
  • Basic SAS concepts
  • SAS statements
  • SAS syntax rules

SAS dataset

  • SAS libraries accessing
  • Datasets reading
  • SAS data as input
  • Observations & variables
  • Data portions
  • Working with Excel worksheets
  • Importing Excel file

Descriptors

Raw data files

  • Reading of raw data
    Raw data compilation
  • Procedures and techniques for validating and cleaning data

Manipulating data

  • Creating of Variables
  • Sub setting
  • Combining Datasets
  • Merging the SAS dataset

Enhancing Report (ODS systems)

  • Details of Global statements
  • Working with Format & Label Statements
  • User Defined formats
  • Sending output to external files

Summary Reports with FREQ and MEANS Procedure

Controlling Input and Output: Multiple SAS Datasets and Selecting Variables & Observations

Summarizing Data

Reading Raw Data Files

Transpose procedure

Data Transformations

SAS Arrays

Excel:

  • Introduction and Basics
  • Excel Basic formulas: Add, subtract, multiply, divide, average, % etc.
  • Using Menus
  • Formatting a Worksheet: Creating Headers, Footers, and Page Numbers, Print Titles, Gridlines, margins , orientations
  • Excel Data Validation — Filters & Grouping in Excel
  • Excel Formulas & Functions — Learn with Basic Examples
  • Logical Functions in Excel — IF, AND, OR, Nested IF & NOT
  • How to Create Charts in Excel — Types & Examples
  • Data Analysis & Pivot Tables

Statistics:

  • Annova: Single Factor, Two Factor with and without Replication
  • Descriptive Statistics
  • F-Test Two-sample for variances
  • Correlation
  • Covarience
  • Exponential Smoothing
  • Fourier analysis
  • Histogram
  • Random Number generation
  • Rank and Percentile
  • Regression
  • Sampling
    • T-test
    • Z-test: two-sample for means

SAS – Clinical

  • What is Clinical Research
  • Introduction and procedure
  • ICH Guidelines – introduction
  • GCP guidelines
  • Good programming Practices
  • SAS in Clinical Research
  • Demo – Clinical trial study
Clinical Data Interchange Standards Consortium
  • Introduction to CDISC
  • Guidelines for CDISC
  • Terminology
    CDISC – SDTM
    CDISC – ADaM
    CDISC – SEND
    Clinical study Protocol
  • Demo for SAP & CRF
  • Study Populations
  • Sample size Calculation
  • Randomization
  • SAS Programming
  • Table , Listings and Figures
    CDISC mapping
  • Dataset – as per guidelines
  • Validation
  • Annotation
Theory-Clinical Research

Module 1: Introduction to Clinical Research

Module 2: Conceptualizing the Clinical Trial Study/Protocol

Module 3: Protocol Review, Implementation & Monitoring

Module 4: Data Quality & Results Reporting

Module 5: Topics of Special Interest

Basics to Clinical Research

  • Pre-clinical details
  • What is Contract Research Organizations-CRO
  • Who is called sponsor and introduction
  • Introduction to clinical trials: Types, Designs and Phases
  • ICH GCP guidelines (ICH E6, E3 and E9)
  • Details of INDA, NDA and ANDA
  • Study protocol – mandatory requirements
  • CRF – contents
  • ICF – format and requirements
  • Subject – safety and AE reporting
  • Study monitoring
  • Responsibilities of clinical research associate
  • Responsibilities of principal investigator
  • Study safety aspects
  • SOPs required for clinical study
  • Source data
  • Clinical site monitoring
  • Review boards (IRB)/IEC
  • Mandatory documentation needs
  • MeDRA Coding
  • What are AEs and categorizing the AEs
  • AE closing
  • Investigator’s Brochure
  • Role of FDA and EMA in clinical research
Theory-Clinical Data Management
  • Introduction to CDM
  • CDM process
  • CDM life cycle
  • Study – start up, conduct and closing
  • CDM- live examples
  • CRFs – how to prepare and types
  • Guidelines – GCP
  • 21 CFR – guidelines introduction
  • Data recording and storing
  • Data accessing
  • Data capturing
  • Setting specifications for data check
  • Pre closure Checks
  • Database – creation, edit -checks and freezing
  • CRF – annotation
  • Data entry
  • Proc compare by SAS
  • Data management – discrepancies, queries and resolutions
  • DCFs
  • Coding
  • Audit Trail
  • EDC – tool for data base
  • Excel based database
Regulatory Affairs
  • ICH Guidelines
  • Regulatory Guidelines: USFDA/EMEA/ CDSCO
  • Regulatory Submission
  • Drug Master Files
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