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Training Levels and Eligibility

1. Advance Training: Participants must be proficient in Base module of SAS Software.

2. Entry Level Training: Knowledge of any computer programming language is desirable.

Candidates having data analytical aptitude and possessing at least a Bachelor degree in any discipline are encouraged for this training. A degree in Computer Science, MCA, BTech, Pharmacy, Commerce, Biotechnology, Life Sciences, or any related discipline will be an advantage. SAS Programmer jobs do not specifically require a degree in Computer Science.

1. Introduction to New Drug Development Process (2 hours)

The purpose of this lecture is to familiarize the participants with new drug development process, Clinical Trials Phases (I, II, III, IIIa, IIIb, IV), and various terminology commonly used in the pharmaceutical and healthcare industry, such as NDA, BLA, Label, Patent Licensing, ICH, GCP, FDA, EMPEA, 21 CFR Part 11, Label Update, Ethical Committee, IRB, DSMB, ISE, ISS, SCE, SCS, Standard Operating Procedures (SOP), etc.

2. Clinical Trials Activities - Brief Details (2 hours)

This lecture will provide information on various activities in clinical trials, such as Protocol Development Process, Case Report Forms (CRFs), Statistical Analysis Plan, Clinical Data Management (CRF Annotation, data Entry, Data Edit checks, Tracking of queries and resolutions, Coding of Adverse Events and Concomitant Medications, Quality Assurance of Database, Database Clean-up, Database lock, Data transfer to sponsor, Database unlock and re-lock), Statistical Analysis & Reporting (Programming of Safety and Efficacy Tables, Listings, and Figures, Unblinding of Randomization Code, Integrated Analysis), Release of Clinical Trials Analysis Results, Medical Writing (Pre-Meeting NDA Briefing Package for submission to FDA, Clinical Study Report, Integrated Summary of Safety and Efficacy, Clinical Overview, Statistical Overview, Publishing of Documents in GlobDoc for Electronic Submission), Templates of Protocol, CRF, SAP, CSR, Project timelines and deliverables, etc.

3. Developments in NDA Submissions to FDA/Regulatory Authorities - Brief details (1 hour)

This lecture will apprise the participant on development in the documentation of New Drug Application (NDA) submitted to regulatory authority referring to a check list of items included in NDA submissions, On Paper Submissions, Electronic Submission (eNDA, eCTD), Common Technical Document (CTD), SAS Database as transport files, CDISC compliant SAS database, etc.

4. SAS Programmer/Analyst- Training (80 hours)

  • Write Programming Specifications 
  • Create Derived Datasets according to CDISC, SDTM and ADaM Standards 
  • Program Safety and Efficacy Tables, Listings, and Figures 
  • Create spreadsheet for tracking of programs development and validation
  • SAS Code to include usage of: 
    • Data Steps 
    • Proc UNIVARIATE, FREQ, MEANS, GLM, MIXED 
    • Macros 
    • Proc Report for display of results in summary tables and listings
    • SAS Graph module 
    • ODS 
  • Special tips for handling of titles, footnote, pagination of output, numbering and renumbering of TLFs 
  • Validation of Tables Listings and Figures 
    • Write independent SAS programs for validation 
    • Write validation documents 

Training Plan

  • Two weeks intensive training 
  • Morning session: 
    • Lectures 
  • Afternoon session: 
    • Tutorials 
    • One-to-one meetings 
  • Each participant will program: 
    • 20 Standard Tables of Efficacy and Safety Summary 
    • 5 Listings 
    • 2 Graphs 
  • Training on a real data of a clinical trial 
  • Training will be similar to an on-the-job training
  • Online guidance and tutoring for 3 months after training 
  • Award of Training Certificates 
  • Placement guidance

 

List of Standard Tables and Listings to be programmed by Participants on

Advance Training as a SAS Programmer

  • Subject Disposition 
  • Premature Discontinuation 
  • Demographic and Baseline Characteristics 
  • Medical History
  • Concomitant Medication 
  • Extent of Exposure and Drug Compliance 
  • Primary Efficacy Endpoint - Descriptive Statistics 
  • Secondary Endpoint - Descriptive Statistics 
  • Analysis of primary efficacy endpoints 
  • Analysis of secondary efficacy endpoints 
  • Kaplan Meier Analysis of Time to Event
  • Proportional Hazard Analysis 
  • Responder Analysis 
  • Center-wise Descriptive Statistics of Primary Efficacy Endpoint 
  • Adverse Events 
  • Serious Adverse Events 
  • Vital signs 
  • Physical examination
  • Laboratory Data - Hematology and Blood Chemistry 
  • Pharmacokinetics Data Analysis 

Listings

  • Patient Demographics 
  • Efficacy Evaluations 
  • Adverse Events 
  • Adverse Events Leading to Discontinuations
  • Lab Analytes with High and Low Flags 

Figures

  • Study center wise mean values of efficacy response 
  • Response over time