Clinical SAS Course Training

Clinical SAS refers to the application of SAS (Statistical Analysis System) in the pharmaceutical, biotechnology, and healthcare industries for clinical trial data analysis and reporting. It plays a crucial role in regulatory submissions to agencies like the FDA (U.S.), EMA (Europe), PMDA (Japan), and other global health authorities.

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Clinical SAS Course Training Upcoming Batches

Demo Date

30th June

Time

09:00 AM TO 10:00 AM

Program Duration:

45 day

Learning Format:

JOIP

Course Curriculum

India’s #1 Software Training Institute

KEY HIGHLIGHTS

Data Management & Cleaning

Handling raw clinical data and preparing it for analysis

Statistical Analysis

Applying various statistical procedures to analyze efficacy and safety

Generating Reports & Visualizations

Creating tables, listings, and figures (TLFs)

Regulatory Submissions

Formatting data as per CDISC (SDTM & ADaM) standards for FDA/EMA approval

Comprehensive Training

Key Features

Skills Covered

Exclusive Training

JOB ORIENTED INTENSIVE PROGRAM (JOIP)

INTENSIVE & INTERNSHIP PROGRAM (I&I)

Any Graduate/Any Qualifying Year/Gap
Internship With Real time Environment
8 Hours Training, 3-9 Months
Soft Skills Training
Aptitude Training
Project Environment From Day 1 Until The Student Gets Placed
Project Experience Until Student Gets A Job
Every Week Mock Interview
Get Access To 50+ Live Resumes.
Get Access To QT Master LMS
Up To 3 Live Projects Training
Internship Certificate From Ramanasoft
Dedicated Placement Officers

Eligibility

Introduction to Clinical SAS & Clinical Trials

Overview of SAS in the Pharmaceutical Industry
Role of a Clinical SAS Programmer
Introduction to Clinical Trials & Phases (I-IV)
Understanding Case Report Forms (CRF)
Overview of Regulatory Guidelines (FDA, EMA, ICH, HIPAA)

Module 2: SAS Programming Essentials

Introduction to the SAS Environment
Data Step & PROC Step
Importing & Exporting Data (Excel, CSV, XML, SQL)
Data Cleaning & Missing Value Handling
Merging & Transforming Datasets
SAS Functions (Date, String, Numeric, Statistical)
Conditional Statements & Loops (IF-THEN-ELSE, DO, DO WHILE)

Module 3: Clinical Data Management

Understanding Clinical Trial Data (Demographics, Lab Data, Adverse Events)
Sorting, Filtering, and Transposing Clinical Datasets
Handling Missing & Incomplete Data
Data Validation & Quality Control Techniques
Introduction to SDTM & ADaM Standards

Module 4: Statistical Analysis for Clinical Trials

Descriptive Statistics – PROC MEANS, PROC FREQ, PROC UNIVARIATE
Inferential Statistics – T-tests, ANOVA, Chi-Square, Regression Models
Survival Analysis – Kaplan-Meier, Cox Proportional Hazard Model
Adverse Event Analysis – Identifying Drug Safety & Side Effects
Handling Large Clinical Datasets

Module 5: CDISC Standards (SDTM & ADaM)

Introduction to CDISC (Clinical Data Interchange Standards Consortium)

Study Data Tabulation Model (SDTM)

Creating SDTM Domains (DM, EX, AE, LB, VS)

Analysis Data Model (ADaM)

Creating ADaM Datasets (ADSL, ADAE, ADLB)

Metadata Preparation – Define.XML, SAS XPT Files

Validation with Pinnacle 21

Module 6: Clinical Reporting & Submission

Generating Tables, Listings, and Figures (TLFs)
Creating Clinical Reports using PROC REPORT & PROC TABULATE
Output Delivery System (ODS) – Exporting reports in Excel, PDF, RTF, HTML
Preparing Clinical Study Reports (CSR) for Submission
FDA Submission Process & Requirements

Module 7: SAS Macros & Automation

Introduction to SAS Macro Programming
Creating & Using Macro Variables
Writing Reusable Macro Programs
Automating Clinical Data Processing

Module 8: Real-World Project & Case Studies

End-to-End Clinical Trial Data Analysis Project
Working with Real Clinical Datasets (SDTM, ADaM)
Hands-on Regulatory Submission Workflow
Resume Building & Interview Preparation

Why Choose Quality Thought

100% Success Rates in the Placement for Skilled People

Placements and Career Success:Setting 100% Success Rates in the Placement for Skilled People
Flexible learning options: The beauty of it is that you can chose to take the programs either online, offline or even a combination of both.
Millions of learners:Be part of the ever growing quality thought family comprising of people who are changing the world and turning their dreams into realities through quality thought programs. To get all the motivation you need and also find people on the same level as you in their learning process.
Cutting-edge courses:Be prepared and have the best skills and knowledge using Quality Thought’s curriculum which will be up-to-date for the needed job market.
Innovative teaching methods: Enjoy an interesting and active learning process with Quality Thought’s approach that makes learning easier and more effective.
Career support:Take advantage of a Resume Writing Service, Interview and Life Skills Training, and Job Placement for a good and well-paying job start.
Positive student experiences:Produce or acquire simple and specific examples of improvements in the behavior of past students, when using Quality Thought’s programs.

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Clinical SAS Course Training

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Clinical SAS Course Training Upcoming Batches