CLINICAL

SAS Clinical Efficacy

SAS Clinical Efficacy Programming – From Data to Decision Unlock the core of clinical trial success by mastering efficacy programming ... Show more

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nova_admin

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The purpose of learning SAS Clinical Efficacy is to:

Analyze and report treatment effectiveness in clinical trials using regulatory-compliant statistical methods and datasets.

It enables professionals to:

Work with efficacy endpoints (e.g., primary, secondary outcomes)
Create and validate SDTM/ADaM efficacy datasets
Generate TLFs for efficacy results
Support regulatory submissions to FDA/EMA with accurate data
Interpret clinical outcomes and support drug approval decisions

This skill is essential for SAS programmers, biostatisticians, and clinical data professionals involved in drug development.

Main Features

1. Efficacy Data Handling
- Importing and cleaning subject-level data
- Managing visit dates, dosing info, and protocol deviations
🔹 2. Efficacy Endpoint Derivation
- Creating variables for Primary, Secondary, and Exploratory endpoints
- Time-to-event, change-from-baseline, and responder endpoints
🔹 3. ADaM Efficacy Datasets
- Building ADSL, ADQS, ADRS, ADTIME, etc.
- Using BDS and OCCDS structures aligned to CDISC standards
🔹 4. Statistical Analysis Implementation
- Applying hypothesis tests (t-test, ANOVA, Cox regression)
- Programming estimands and handling missing data as per SAP
🔹 5. TLF Generation

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What is the target audience?

This training is designed for individuals aiming to work in clinical trial data analysis and regulatory reporting roles. Ideal participants include:

🔸 Clinical SAS Programmers
- Looking to specialize in efficacy datasets and TLF generation.
🔸 Biostatisticians & Statistical Analysts
- Needing to implement and validate statistical methods for efficacy analysis.
🔸 Clinical Data Analysts
- Involved in data preparation, review, and transformation for efficacy reporting.
🔸 Pharma & CRO Professionals
- Transitioning into data analysis roles from data management or clinical operations.
🔸 CDISC/ADaM Specialists
- Seeking hands-on application of ADaM standards for efficacy domains.
🔸 Fresh Graduates in Life Sciences, Pharmacy, Statistics, or Bioinformatics
- Entering the field of clinical research with a focus on statistical programming.
🔸 Healthcare Data Professionals
- Exploring opportunities in clinical trial analytics and regulatory submissions.

Module 1: Introduction to Efficacy in Clinical Trials

Module 2: Study Protocol & Statistical Analysis Plan (SAP)

Module 3: Clinical Data and Population Flags

Module 4: Key Efficacy Datasets

14
Lesson 1: ADaM Datasets for Efficacy

Text lesson
ADSL (Subject-Level): One record per subject with demographics and flags.

ADRS (Response): Derived response data (e.g., tumor response).

ADLB (Lab): Lab results used to assess efficacy.

ADVS (Vital Signs): Vital signs relevant to efficacy.

ADQS (Questionnaires): Patient-reported outcomes.

ADAE (Adverse Events): May support efficacy (e.g., symptom relief).

Module 5: Time-to-Event (Survival) Analysis

15

Module 1: Time-to-Event (Survival) Analysis

Text lesson

Explaining the concepts and business logics on ADTTE Dataset.

Module 6: Statistical Procedures in SAS

16

Lesson 1: Statistical Procedures in SAS

Text lesson

Applying different technqiues for safety and efficacy report.

Module 7: TLFs – Tables, Listings & Figures for Efficacy

17

Lesson : Efficacy Tables

Text lesson

A detail and indepth technqiues of TLFs

Module 8: Mock Shells & SAP Mapping

18

Lesson : Working with Mock Shells & SAP Mapping

Text lesson

Mock Shells (in Clinical Trials):
Mock shells are sample table templates created before actual data is available. They define the layout, structure, titles, footnotes, and formatting of tables, listings, and figures (TLFs) to ensure clarity and standardization during statistical reporting.

SAP Mapping:
SAP (Statistical Analysis Plan) mapping is the process of aligning study protocol elements and analysis objectives with datasets, variables, and TLF outputs, ensuring that each part of the SAP is implemented accurately during statistical programming.

Module 9: Validation Techniques

19

Lesson : Applying Validation Techniques

Text lesson

A different validation technqiues using SAS.

1. What is this course about?

This course focuses on teaching how to program efficacy data in clinical trials using SAS. You’ll learn how to derive efficacy endpoints, build ADaM datasets, and generate statistical reports (TLFs) that are required for regulatory submissions.

2. Do I need prior SAS knowledge to join this course?

Yes, basic knowledge of SAS programming is required. If you're familiar with DATA steps, PROC SQL, and working with datasets, you’ll be ready. If not, we recommend completing our SAS Clinical Fundamentals course first.

3. Is this course suitable for freshers?

Yes, this course is beginner-friendly if you already know basic SAS. We start with the fundamentals of efficacy in clinical trials and gradually move to advanced real-time programming scenarios.

4. Will this course help me get a job in SAS clinical domain?

Absolutely. Efficacy programming is a key skill that top CROs and pharma companies look for. By learning how to build regulatory-compliant datasets and TLFs, you'll be ready for interviews and real-world projects.

5. Will I get hands-on experience with datasets and code?

Yes. You'll work with mock SDTM and ADaM datasets, write SAS code, derive efficacy variables, and generate outputs just like in a real industry setting.

6. Do you cover regulatory expectations like FDA, CDISC, ADaM standards?

Yes. The course is designed to align with CDISC ADaM guidelines and regulatory expectations from the FDA and EMA.

7. What datasets will I learn to create?

You will work on datasets like ADSL (subject-level), ADEFF (efficacy), ADQS (questionnaires), and more — all tailored for efficacy analysis.

8. Will I learn to create TLFs for efficacy?

Yes. You will learn to code efficacy Tables, Listings, and Figures including change from baseline tables, LS Means, p-values, and KM plots.

9. Is there any project or certification?

Yes. You'll complete a capstone project with full programming and documentation. On successful completion, you'll receive a certificate that’s valuable for interviews and job placements.

10. What kind of job roles can I apply for after this course?

After this course, you can apply for roles like:

SAS Clinical Programmer (Efficacy)

ADaM Programmer

Statistical Programmer

Clinical Data Analyst (Efficacy)

Coming Soon: SAS Clinical Efficacy Programming Training!

We are excited to announce that Nova8Labs will soon be launching a specialized training program on:

SAS Clinical Efficacy Programming – From Data to Decision

This hands-on course is designed to prepare you for real-world clinical programming roles with a strong focus on efficacy dataset creation, statistical reporting (TLFs), and regulatory expectations (FDA/EMA).

Launch Date: Coming Soon
Who Can Join: Clinical SAS beginners, freshers, and working professionals
Mode: Online with practical projects and certificate from NOVA8LABS

For further details and early access,
📩 Contact us at: info@nova8labs.com
📞 Phone: 8309396036
🌐 Website: www.nova8labs.com

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