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Diploma Program

Biostatistics and Programming

Program Objective

This program provides a detailed understanding of statistical principles and programming tools used for collecting, organizing, analyzing, interpreting, and reporting clinical trial data. Participants will gain in-demand expertise in biostatistics, SAS programming, CDISC compliance, and the application of R and Generative AI in clinical research.

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The program helps learners streamline data workflows, automate clinical reporting, and meet global regulatory standards, making them job-ready for statistical and programming roles in the biopharma and clinical research industries.

Duration: 6 Months
Mode: Online (Instructor-led) + Project

Level: Diploma – Industry-Ready

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Certification

  • Diploma in Biostatistics and Programming – Issued by IDDCR Global Institute

  • SAS Programming Essentials Certificate (Optional)

  • R for Clinical Analysis Certificate

  • Project/Internship Completion Certificate

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Program Benefits

  • Industry-designed curriculum aligned with regulatory expectations

  • Practical exposure with SAS, R, CDISC, and Generative AI tools

  • Short-term, high-return pathway to a career in biostatistics

  • Ideal stepping-stone for MSc Clinical Research graduates or data professionals

  • Prepares for global job roles and further advanced certifications (e.g., Base SAS, CDISC SDTM)

  • Support for internships and placement in CROs, pharma, and healthcare analytics firms

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Career Outcomes

After completing this diploma, learners can apply for the following roles:

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  • Biostatistician (Jr. or Associate level)

  • Statistical Programmer (SAS Programmer)

  • Clinical Data Analyst

  • CDISC Programmer (SDTM/ADaM)

  • Clinical R Programmer

  • Trial Report Analyst

  • AI-Powered Medical Writer (Tech-enabled)

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Assessment & Evaluation

  • Module-wise Quizzes and Assignments

  • Hands-on Programming Tasks in SAS and R

  • Biostatistics Case Study Evaluations

  • Final Capstone Project + Viva (Internal + Industry Panel)

  • Minimum 60% passing criteria for certification

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Skills You Will Learn

  • Clinical Biostatistics with hands-on case applications

  • Base and Advanced SAS Programming for Clinical Data

  • CDISC Standards (SDTM/ADaM basics)

  • Use of R for Statistical Analysis

  • AI-enhanced reporting and automation

  • TLF generation and data validation techniques

  • Regulatory-aligned statistical submission practices

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Eligibility

  • Final year students & graduates in Life Sciences, Pharmacy, Biotechnology, Nursing, BPT, MBBS, BDS, or Allied Health Sciences

Your journey into clinical analytics starts here.

In today’s clinical research landscape, biostatistics and programming are central to every drug development decision. The Diploma in Biostatistics and Programming is your launchpad into a career where data, science, and technology come together to improve human health. Whether you're a fresh graduate or a working professional, this program equips you with real-world skills in statistical analysis, SAS, R, CDISC, and Generative AI. You'll not only learn to code—you’ll learn to think like a clinical data scientist, solve complex problems, and contribute to faster, safer drug development across global pharma and biotech industries.

Course Contents

Module 1: Clinical Research Foundation

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  • Drug Development Process & Clinical Trial Phases

  • Protocols, CRFs, eCRFs, and Study Designs

  • Roles of Biostatistics in Clinical Trials

  • Regulatory Overview (FDA, EMA, DCGI)

  • ICH-GCP Overview

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Module 2: Biostatistics Essentials

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  • Descriptive & Inferential Statistics

  • Hypothesis Testing, P-Values, Confidence Intervals

  • t-Test, ANOVA, Chi-square, Regression, Survival Analysis

  • Sample Size Estimation

  • Hands-on with Clinical Case Scenarios

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Module 3: Base SAS Programming for Clinical Trials

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  • Introduction to SAS: Data Steps, PROC, Formats

  • Data Manipulation, Import/Export, Merging

  • PROC SQL, PROC TRANSPOSE, Macros

  • Generating Listings, Tables, and Figures (TLFs)

  • Automating and Validating Clinical Reports

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Module 4: R Programming for Data Science

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  • Introduction to R Environment & Syntax

  • Data Cleaning and Transformation using dplyr & tidyr

  • Data Visualization using ggplot2

  • Biostatistical Functions in R

  • Integration with Clinical Trial Reporting

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Module 5: CDISC Essentials

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  • Overview of CDISC Standards

  • Introduction to SDTM and ADaM

  • Domain Mapping & Define.XML

  • CDISC Controlled Terminologies

  • Regulatory Expectations: FDA & EMA Submission Standards

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Module 6: Generative AI for Programming

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  • Real-world dataset assignment

  • Statistical Report Writing

  • SAS + CDISC Project (ADaM or SDTM Mapping)

  • Presentation and Viva with Expert Panel

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Module 7: Capstone Project / Internship

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  • Introduction to Generative AI & LLMs in Pharma

  • Prompt Engineering for Data Analysis

  • Automating SAS Code Generation

  • AI-Powered Statistical Summaries & Report Drafting

  • Ethical Use & Validation of AI Outputs

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$12.8 Billion Market by 2033

The global Biostatistics Consulting Service Market is projected to reach $12.8 billion by 2033, with significant growth in clinical trials and an increasing demand for skilled biostatisticians and programmers.

Launch Your Career in the Biostatistics and Programming

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