The Simplest Guide™ to Clinical Data Analysis with SAS from Coursera

In the realm of pharma and life sciences, clinical data analysis is a critical skill that demands precision and expertise. This course breaks down the intricate processes involved in analyzing clinical trial data using SAS, making it accessible to professionals at all levels. You'll begin with an introduction to the industry, understanding the components and phases of clinical trials, and the various types of data and reports involved.

The course then guides you through the essential clinical study documents, including the study protocol, informed consent, inclusion-exclusion criteria, and the Statistical Analysis Plan (SAP). By mastering these documents, you'll lay a solid foundation for building comprehensive Clinical Study Reports (CSRs). The hands-on approach of the course ensures that you not only learn the theoretical aspects but also how to apply them practically.

As you progress, you'll dive into the detailed steps of programming CSRs using SAS. From understanding case report forms and importing raw data to deriving critical variables like AGE, SEX, and RACE, and finally compiling all the summary statistics, the course walks you through each step with clarity. By the end, you'll have the confidence to produce polished, professional-grade reports, essential for advancing your career in clinical data analysis.

This course is designed for data analysts, statisticians, and professionals in the pharma and life sciences industries who want to deepen their understanding of clinical data analysis using SAS. A basic understanding of clinical trials and prior experience with SAS programming is recommended but not required.

What's inside

Syllabus

Introduction

In this module, we will introduce the foundational aspects of the pharma/life sciences industry, focusing on the clinical trial process. We’ll explore industry components, phases of clinical trials, and the various data types and reports integral to clinical research.

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Breaks down the processes involved in analyzing clinical trial data using SAS, which is a critical skill that demands precision and expertise in the pharma and life sciences industries

Guides learners through the essential clinical study documents, including the study protocol, informed consent, inclusion-exclusion criteria, and the Statistical Analysis Plan (SAP)

Walks learners through each step of programming Clinical Study Reports (CSRs) using SAS, from importing raw data to deriving critical variables and compiling summary statistics

Prior experience with SAS programming is recommended, suggesting that learners without this background may find the course challenging without additional preparation

Reviews summary

Clinical data analysis with sas

According to learners, this course provides a positive and practical introduction to clinical data analysis using SAS. Many students found the course content to be well-structured and the explanations clear, making complex topics accessible. The emphasis on hands-on application and working with clinical study documents like SAPs and CRFs was particularly appreciated. While the course is titled 'Simplest Guide,' some students felt that prior familiarity with basic SAS programming was helpful, though not strictly necessary. Overall, it's seen as a valuable resource for professionals in the pharma and life sciences industry looking to apply their skills to clinical trial data.

Some prior SAS experience is beneficial.

"While it says no prior SAS needed, having some basic knowledge made it much easier..."

"Beginners might find the SAS coding parts challenging without any prior exposure."

"I had some SAS background, which I think was helpful for keeping up with the examples."

Complex topics are made easy to understand.

"The instructor explained difficult concepts in a way that was easy to grasp."

"Content is delivered in a clear and concise manner..."

"Lectures were well-structured and easy to follow, even for someone newer to the field."

Explains concepts specific to clinical trials.

"Understanding the context of clinical trial phases and documents like SAP was very useful."

"I appreciated how the course tied the SAS programming back to the specific needs of clinical studies..."

"The modules on CRFs, protocols, and SAPs laid a solid foundation before diving into the coding."

Helps build job-relevant SAS skills.

"I learned how to apply SAS programming specifically to analyze clinical trial data effectively."

"The course provided practical techniques for generating summaries and deriving variables for clinical reports."

"I found the demos on using SAS for CSR building very applicable to my daily work..."

"This course helped me understand how SAS fits into the clinical data pipeline."

Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in The Simplest Guide™ to Clinical Data Analysis with SAS with these activities:

Review Basic Statistics Concepts

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Reinforce your understanding of fundamental statistical concepts to better grasp the analytical methods used in clinical data analysis.

Browse courses on Statistical Analysis

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Review key statistical terms and formulas.
Work through practice problems involving descriptive statistics.
Familiarize yourself with hypothesis testing procedures.

Practice Basic SAS Programming

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Sharpen your SAS programming skills to efficiently manipulate and analyze clinical data.

Browse courses on SAS Programming

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Review SAS syntax and data step operations.
Practice importing and exporting data in SAS.
Write simple SAS programs to calculate summary statistics.

Read 'The Little SAS Book'

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Use this book to gain a solid foundation in SAS programming, which is essential for completing the hands-on exercises in the course.

View Exercises and Projects for The Little SAS Book,... on Amazon

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Read the chapters covering data input and output.
Practice the examples provided in the book.
Review the sections on data manipulation and analysis.

Four other activities

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Participate in a SAS Study Group

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Collaborate with peers to discuss course concepts, troubleshoot SAS code, and reinforce your understanding of clinical data analysis techniques.

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Join or form a study group with other students.
Discuss challenging topics and share insights.
Work together on practice problems and assignments.

Create a SAS Code Snippet Library

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Build a collection of reusable SAS code snippets for common clinical data analysis tasks, such as data cleaning, variable derivation, and report generation.

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Identify frequently used SAS code patterns.
Document each code snippet with clear explanations.
Organize the library for easy access and retrieval.

Analyze a Sample Clinical Dataset

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Apply your SAS programming skills to analyze a publicly available clinical dataset and generate summary reports.

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Obtain a sample clinical dataset from a public source.
Write SAS code to clean, transform, and analyze the data.
Generate summary tables and figures to present your findings.
Document your code and analysis process.

Read 'Pharmaceutical Statistics Using SAS'

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Use this book to deepen your understanding of the statistical methods used in clinical data analysis and to prepare for more advanced topics.

View Putting Knowledge to Work on Amazon

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Read the chapters relevant to clinical trial design.
Study the examples of statistical analysis using SAS.
Review the sections on regulatory submissions.

Career center

Learners who complete The Simplest Guide™ to Clinical Data Analysis with SAS will develop knowledge and skills that may be useful to these careers:

Clinical Data Analyst

Clinical data analysts are vital in the pharmaceutical and life sciences sectors, working with data from clinical trials. This role involves managing, interpreting, and reporting on clinical trial data, ensuring accuracy and compliance with regulatory standards. This course helps build a foundation for building comprehensive clinical study reports. The course's focus on SAS programming for CSRs will be especially useful. The ability to derive variables like age, sex, and race, and creating summary statistics, is essential for a clinical data analyst. Developing these skills will be directly applicable to day-to-day responsibilities.

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Statistical Programmer

Statistical programmers use programming languages like SAS to manage and analyze data from clinical trials. This role focuses on generating tables, listings, and figures for reports that are vital to clinical study analysis. This course has a clear focus on programming CSRs using SAS, and this provides the skills needed to produce professional-grade reports. The course guides you through the detailed steps of programming CSRs and also covers deriving variables and compiling summary statistics, a key element for any statistical programmer. This knowledge will be directly applicable to the job.

See salaries and explore the career path for Statistical Programmer

Biostatistician

Biostatisticians apply statistical methods to biological and health-related data, particularly in clinical trials. The role involves designing studies, analyzing data, and interpreting results to inform research and guide healthcare decisions. This course may be particularly useful for learning how to produce polished, professional grade reports. This course delves into the essential documents involved in clinical studies, such as the clinical study protocol and the statistical analysis plan. By mastering these documents, a biostatistician can ensure their data analysis is accurate and in line with study objectives. Programming skills in SAS, especially for clinical study reports, enhances a biostatistician's ability to contribute effectively.

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Clinical Research Associate

Clinical research associates are involved in the oversight and management of clinical trials. This includes monitoring study progress, ensuring compliance with protocols, and handling data collected during trials. Understanding the types of data and reports used in clinical research is crucial. This course introduces the components and phases of clinical trials and can help build a foundation in the industry. The ability to understand and work with clinical study documents, such as the study protocol and informed consent, is essential for clinical research associate. This course helps one to master these, making it valuable for this role. Learning how to build CSRs using SAS will directly assist a clinical research associate in their responsibilities.

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Data Manager

Data managers are responsible for overseeing the integrity and quality of data collected during clinical trials. They develop and implement systems for data collection, storage, and analysis. This course introduces the various data types and reports integral to clinical research. Also, the course delves into essential documents involved in clinical studies, such as clinical study protocol and statistical analysis plans. Understanding these documents is crucial for a data manager. The course's practical approach, especially in using SAS to manage data and create reports, is directly relevant. A data manager will find that this course directly helps them learn how to improve the quality of data.

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Research Scientist

Research scientists in the pharmaceutical industry design and conduct experiments, analyze data, and contribute to the development of new drugs and treatments. Understanding how to work with clinical trial data is very helpful for a research scientist in the pharmaceutical industry. This course guides the learner through the creation of clinical study reports using SAS. Mastery of this skill enables a research scientist to effectively analyze data from their research. Their analysis can inform their decision-making, which can have a tremendous impact on new medicines and treatments. This training in clinical data analysis may be useful.

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Clinical Trial Manager

Clinical trial managers oversee the planning, execution, and completion of clinical trials. This includes managing timelines, budgets, and resources, as well as ensuring trials adhere to regulatory standards. This course may be useful in providing an understanding of the data generated in clinical trials. A clinical trial manager benefits from understanding the various types of data and reports used in clinical research. Their understanding of clinical study documents, such as the study protocol and statistical analyses plan, will be aided by this course. Further, their work benefits directly from understanding how to build clinical study reports using SAS.

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Regulatory Affairs Specialist

Regulatory affairs specialists ensure that pharmaceutical products comply with the regulations set by government agencies. They prepare and submit documentation for approval of new drugs and devices and manage regulatory compliance. Familiarity with clinical study reports will assist a regulatory affairs specialist in their work. This course helps build the foundation for clinical study reports. The course’s focus on clinical study documents, like the study protocol and statistical analysis plan, aids a regulatory affairs specialist in understanding these documents. Such knowledge is useful for the review and approval process. This course may be useful.

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Healthcare Consultant

Healthcare consultants provide expert advice to healthcare organizations, including pharmaceutical companies, on strategies and processes. This could include process improvement, compliance, and data analysis. A healthcare consultant would find familiarity with clinical data analysis very useful for consulting with pharmaceutical clients. This course offers a broad introduction to the pharmaceutical industry. It may assist in understanding the data analysis processes used. The course's focus on the steps of creating Clinical Study Reports will be helpful. A healthcare consultant can speak with deeper proficiency if they comprehend the clinical data analysis process. This course may be helpful.

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Pharmacovigilance Specialist

Pharmacovigilance specialists monitor and assess the safety of pharmaceutical products. They collect and analyze adverse event reports and work to ensure the safety of patients. This course offers an introduction to the pharmaceutical industry and the clinical trial process, which can be useful background for understanding how drug safety monitoring is involved. The course’s focus on clinical study documents is relevant for this role. A pharmacovigilance specialist may benefit from understanding the clinical reporting process. This course may be useful.

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Medical Writer

Medical writers create documents about medical research, including clinical trial reports and regulatory documents, for a variety of audiences. This course's focus on creating clinical study reports using SAS is beneficial for crafting high-quality reports. The ability to understand study protocols and statistical analysis plans, as taught in this course, is crucial. A medical writer must accurately interpret and convey this information. This course can help a medical writer improve their understanding of clinical data analysis, which often forms the basis for the documents they produce. This course may be useful.

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Pharmaceutical Sales Representative

Pharmaceutical sales representatives market and sell pharmaceutical products to healthcare professionals. A foundational knowledge of clinical trials can help a sales representative discuss the benefits of their products. Understanding the data generated from clinical trials enhances one's credibility. This course introduces the components and phases of clinical trials, which can be advantageous for a sales representative who interacts with healthcare professionals. Also, the course's focus on clinical study documents may be helpful in learning the regulatory requirements. This course may be useful.

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Public Health Analyst

Public health analysts collect and analyze data related to public health issues. They use data to inform and develop policies and programs. Familiarity with clinical data analysis processes may be useful in this role. This course offers an introduction to the components and phases of clinical trials and provides an understanding of data analysis techniques. Public health analysts may find the course's practical focus on using SAS to manage and report data helpful in their work. The course may be useful.

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Health Informatics Specialist

Health informatics specialists manage and analyze health data, applying it to improve health systems. They work with electronic health records and data analysis tools. This course focuses on importing raw data and deriving critical variables (such as age, sex, and race) using SAS. This can be a helpful introduction to the kinds of data transformations common to health informatics. Also, the course's hands-on approach to creating reports using SAS programming may be valuable. This course may be useful.

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Healthcare Administrator

Healthcare administrators manage the daily operations of healthcare facilities. While this role does not focus on data directly, understanding the processes involved in research and data analysis is helpful for overall management. This course offers an introduction to the pharmaceutical industry and the clinical trial process. It may provide a useful overview of clinical data analysis. The course's focus on clinical study documents and report creation using SAS can be helpful for a healthcare administrator to understand how data influences healthcare decisions. This course may be useful.

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The Simplest Guide™ to Clinical Data Analysis with SAS

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Clinical data analysis with sas

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