Clinical research is an area that is growing quickly and has a key role in drug development and regulatory submission processes. In clinical research, there are two primary areas: Clinical Data Management (CDM) and Clinical SAS (Statistical Analysis System) programming. They are both important to ensure accurate, trusted, and regulatory-compliant clinical trial data. CDM focuses on data collection and validation, whereas Clinical SAS focuses on data analysis and reporting. Knowing the difference will help individuals decide if one domain area fits better with their skill set and career objectives.
In this blog, we will break down the difference between Clinical SAS vs. Clinical Data Management, compare key elements, and help you determine which route you want to take. Whether you are new to clinical research or looking to specialize in one of these two areas, understanding these differences will help you make more informed decisions. CareerInPharma offers industry-quality training programs in Clinical SAS and Clinical Data Management, supporting learners in acquiring industry-ready fundamental skills that enhance their potential for a fulfilling career.
What is Clinical Data Management (CDM)?
Clinical Data Management, also known as CDM, is the process of collecting, cleaning, validating, and managing of clinical trial data that meets standards set by Good Clinical Practice (GCP) to ensure data integrity. Ultimately, CDM aims to present statistically reliable data for clinical trial analysis and results using data that has been identified as having high quality and research integrity, by CDM professionals. CDM professionals are responsible for designing and annotating Case Report Forms (CRFs) and EDC systems; managing data entry, data validation, and query management processes; and ensuring adherence to regulations throughout the clinical trial process. Common job titles include Clinical Data Coordinator, Data Reviewer, Data Entry Operator, and Clinical Data Manager.
What is Clinical SAS?
Clinical SAS is the programming, statistical analysis, and reporting of clinical data using SAS software. SAS programmers are essential to the transformation of validated data into information that is interpretable for regulatory decision-making. SAS Programmers create datasets, validate datasets, tabulate data using industry standards like SDTM and ADaM, program tables, listings, and figures (TLFs), support SAP development, and prepare summaries for submission to regulatory authorities like the FDA or EMA. Common job titles include Clinical SAS Programmer, Statistical Programmer, SAS Analyst, and Principal SAS Programmer.
Responsibilities: CDM vs Clinical SAS
Though CDM and SAS are dependent on one another, they each have different roles. CDM practitioners review, develop, and design CRF’s, do data entry, mapping, validation, and closeout a study. SAS practitioners review CRF’s from a programming perspective, create analysis ready datasets, create macros, TLFs, and compliance to CDISC. The two roles think and operate together as a process in a continuum. CDM time is only data collecting and capturing high quality data, and SAS is taking that data and producing something we can analyse.
Skills and Qualifications
The qualifications and skills needed in these positions are also different. CDM professionals usually have a background in life sciences, pharmacy, biotechnology, or nursing, have knowledge of clinical trial regulations, and experience with any one of a variety of CDM tools like Oracle Clinical or Medidata Rave. Attention to detail and organization are very important. Clinical SAS professionals generally have a similar education background as a CDM professional but need to have a solid skill set in SAS programming, knowledge of CDISC standards, as well as the ability to problem-solve analytically. Holding a SAS certification is an additional benefit. A published study identified the need for soft skills and articulated that communication, time management, and interacting with stakeholders are often the areas of needed training for programmers.
Salary Comparison
Career Growth and Industry Outlook
For both of these disciplines, the overall opportunities for advancement in your career are very promising. The field of Clinical Data Management (CDM) is expanding drastically due to an increased rate of outsourcing to Clinical Research Organizations (CROs), an increase in regulatory requirements and considerations, and advances in technology. There is a career progression in this area that we anticipate leading to senior positions such as Lead Data Manager, Project Manager, and the Head of Data Management. SAS in the Clinical setting also is seeing growth and development, that regulatory bodies such as the FDA utilize SAS based software on a regular basis for compliance purposes, and require SAS submissions. The sheer demand for SAS programmers in India has risen significantly, the reports that we have seen on the Academy of Colleges are indicating a demand of increase of between 50 – 100% for SAS programmers. There is also a career pathway for SAS that could lead to the same senior positions mentioned above; Lead Programmer, Biostatistician, and Project Manager, as your career develops, you will be expected to fill technical and supervisory roles.
Industry Challenges
While this branch of the industry has grown, the industry still faces challenges. CDM professionals must navigate the complexities of increasingly intricate trial designs while ensuring high-quality data within tight timelines. SAS programmers experience high turnover, as many practitioners want to develop new skills and serve as more than repetitive agents. Each domain is feeling the impact of technology as automation, artificial intelligence, and cloud-based data and informatics change the way they are expected to work.
Which Path Should You Choose?
When weighing the two options, think about what personal strengths and interests will help you decide which is right for you. If you feel strongly about accuracy, regulatory compliance, and data quality, then you may find CDM more fulfilling. If you feel that you are more passionate about programming and statistical analyses and better enjoy activities that directly contribute to regulatory reporting, then the SAS programmer role may be better for you. There is no better option; there are two career paths that complement one another, working in unison to ensure clinical research success.
Future Outlook
There is much optimism around the future of both fields. CDM will continue to grow in importance with more decentralized trials, and as real-world data becomes more integrated into clinical research. Clinical SAS will also continue to grow, as advanced analytic capabilities, automation, and machine learning become essential capabilities in clinical research. Both fields, with the global expansion of clinical trials, present stable and fulfilling professional opportunities.
Conclusion
Clinical SAS and Clinical Data Management (CDM) are two critical aspects of clinical research, with each role being equally important to the development of safe and effective medicines. The CDM role focuses on collecting, validating, and ensuring the integrity of all the clinical data collected in the trial. Clinical SAS is the translation of that data into statistical information, including regulatory submissions. CDM and Clinical SAS represent areas of opportunity now and into the future. Ultimately, the decision between going into CDM or Clinical SAS comes down to whether someone prefers to ensure the data is collected, accurate, and planned at the source, or whether a person prefers to use programming and analytics to create the information supplied to Sponsors and regulatory authorities. Either way, both are exciting and fulfilling opportunities to further your career in the life sciences industry, where the opportunity to positively impact human health is significant!
FAQs about Clinical SAS vs Clinical Data Management
1. What is the difference between Clinical SAS and Clinical Data Management?
Clinical Data Management generally involves data collection, data cleaning, and data validation, whereas Clinical SAS involves statistical programming, statistical analysis, and reporting of clinical trial data.
2. Which field has better salary potential?
Clinical SAS programmers generally have higher salaries than CDM professionals, especially at the entry level, due to the technical nature of the role.
3. Do I need a degree in life sciences to get into these fields?
For CDM, a degree in the life sciences, pharmacy, biotechnology, or nursing is desirable, but Clinical SAS requires knowledge of life sciences and programming skills.
4. Are there advancement opportunities in both fields?
Yes, both fields have a robust opportunity for advancement. CDM individuals can move into leadership and project management positions, while SAS programmers can advance themselves to senior programmer, biostatistician, and manager positions.
5. Should I pursue a career in CDM or Clinical SAS?
Your choice should be made based on your skills and interests. If you enjoy working with data and ensuring its accuracy, and are motivated by ensuring that regulatory requirements are met, CDM could be a good fit for you. If you find programming and data analysis enjoyable and are looking for a career in a necessary data management process, Clinical SAS programming could be a good fit for you!
