Certificate in Clinical R Programming

Cytel team in India is growing by leaps and bounds and today Cytel India grows to a team of 400 people spread across current locations in Pune, Hyderabad, Bangalore and Navi Mumbai. Cytel has expanded its delivery from the core SAS Programming and statistics to other clinical domains such as Clinical R Programming, data management, medical writing areas. Cytel’s growth in services is supported by CliPLab – Cytel’s unique skill development machinery by introducing various industry focussed training and skill development programs. In a newly announced program titled C-ClinR  (Certificate in Clinical R Programming) spanning over 6 weeks, CliPLab provides theory and practical training to young graduates/professionals, who are hand-picked to ensure a mix of the right pool of talents with correct aptitude and skill set. The program helps participants to enhance the competency and credibility as a technical professional by attaining relevant practical and theoretical knowledge. 

Why Clinical R Programming ?

R Programming, an open-source tool, is extensively used for data analysis in universities. Professors and researchers in the field of medicine use R for quantitative analysis. Google and Facebook use R Programming for data exploration, model prototyping and predictive analytics. It is the main programming tool for many quantitative analysts in the finance domain. R Programming is a powerful tool with numerous applications: data import and cleaning, exploration and visualization, statistics generation and analyses and trading simulations. Thus, it is popular in varied fields such as finance, bio-science, clinical and life science, supply chain, sports, retail, marketing and manufacturing. 

The two main advantages of R are;

1.       It has been designed specifically for statistical analysis; therefore, programs in R always require fewer lines of code than programs created using other analytical tools.

2.       It is an open-source tool; therefore, it benefits from constant upgrades, improvements, enhancements and contributions from a global community of passionate users and developers.

Using R in a Clinical and Regulatory Environment

The Office of Biostatistics, US FDA, uses R on a daily basis. FDA scientists have written R packages that can be used by other scientists (FDA or non-FDA). It is a popular misconception that the FDA mandates or endorses the use of a specific software package for statistical analysis – this is not true. The FDA in fact encourages using anything that can be validated for correctness, including R. 21 CFR Part 11 regulates electronic records and their storage, not the software that is used to generate reports. No regulation restricts the use of open-source software (including R) at the FDA.

Meanwhile, in the pharmaceutical and clinical research domain, SAS Programming enjoys immense popularity and is widely used, although regulations do not specify or endorse the use of either SAS or R programming software for statistical analysis and generation of reports and graphs. Owing to the advantages and ease of use of both these tools, various organizations are creating talent pools that are trained in both SAS and R Programming.

Considering this, CliPLab launched “ClinR”, a new course in Clinical R Programming and welcomes candidates to join this course. At CliPLab, we are aware that R requires a data analysis background, and therefore, it must be taught in a manner different from Java or Python. Hence, we use relevant clinical datasets as examples and exercises in the ClinR module.

Duration: 6 weeks / 30 hours / Weekend Program (4 hrs on each week end)

Eligibility: Candidates are preferred from:

·         Pharmacy (M. Pharm., B.Pharm.,)

·         Life sciences (M.Sc., PhD - Biotechnology, Bioinformatics, Microbiology)

·         SAS Programmers / Biostatisticians / Data Science professionals

·         Life Science Students / Researchers / Faculties in colleges and universities

Program Outline

The ClinR course module consists of the following topics:

Module	Topic
1.	Introduction to R
2.	Basics of R
3.	Data Structures
4.	Reading Data in R
5.	Writing R Functions
6.	Control Statements
7.	Loops
8.	Group Manipulation
9.	Data Reshaping
10.	Manipulating Strings
11.	Probability Distributions
12.	Basic Statistics
13.	R Graphics
14.	Report Generation

Features of the ClinR course

·         Specially designed for Life Sciences domain by Cytel, a global expert in biostatistics and clinical programming

·         Comprehensive and top-notch Clinical R Programming training

·         Experienced trainers, who are proficient clinical R programmers with exposure to global clients, including large pharmaceutical and biotech companies

·         Coverage of fundamentals of clinical operations and basic statistics

·         Practical exposure to R Programming using clinical data sets and case studies

·         Regular assessments to improve and evaluate performance

Program Fees:

• This self-financed program would require the investment of Rs. 25,000/- + Applicable tax

Mode of Payment:

o    Payment can be done by Cheque/DD/Credit Card/Debit card/Online Transfer

First C-CAP Batch in Pune Felicitated

We recently organized the convocation ceremony for our very first C-CAP batch from Pune. The students were looking forward to this event for a long time – so much that some of them travelled from Mumbai and Noida just to resurrect some of the great moments of their student lives.  The event was also attended by our existing students who were thrilled with the opportunity to hear the experiences of their seniors as they stepped into the corporate world.

The guest of honor for the ceremony was Mr. Ajay Sathe (CEO, Cytel India) who happily agreed to grace the occasion and share his valuable thoughts for a successful career with the young graduates.

The young graduates have undergone a rigorous training program in  SAS^® 9.4 followed by hands on  experience and on-the-job training at Cytel Statistical Software & Services Pvt Ltd. The C-CAP program has groomed them on various facets of a successful career in Clinical Programming – Domain Knowledge, Statistics Awareness, Therapeutic Areas, Industry Standards, Practical Assignments and Soft skills. The comprehensive structure of the program has ensured that students from diverse educational background are able to emerge as versatile professionals. As shared by Kaveri, our mentor, the diversity in the batch has actually fostered peer-learning and taken the experience to next level.

 In our earlier blog, we had announced that our C-CAP batches were ready to be hired by the market. Thanks to the capability shown by our students, we have been able to clock 100% placement record for the first two batches – one from Pune and the other from our Hyderabad facility.  The students from Pune batch have been placed with reputed CROs such as TCS, Accenture and Inventive. This has once again established the viability of our systematic approach towards talent development.

Previously there was a myth that one must be statistics background to have a successful career in this industry; but with the grand success of our students it has been proved that the statistical knowledge provided in C-CAP is helpful in cracking the rigorous recruitment processes of MNCs irrespective of the student’s background. 

Watch some of our participants share their experiences with C-CAP.

         

The graduates were quite enthusiastic to share their experiences from their stint with the corporate world. Here are some of the useful insights from the interaction: 

1.     An appreciation of statistics helps a lot in cracking the rigorous recruitment process followed by MNCs for clinical programmers

2.     A sound knowledge of the domain is inevitable to navigate confidently through your job responsibilities in Clinical Trial Services Industry

3.     The exhaustive sessions on the safety domains – a unique offering as part of C-CAP, gives you an edge over your peers – both during recruitment process as well as on the job

The graduates were quite satisfied with the training provided on various classes under Safety domains - such as general observational class, special purpose class etc. One of our students shared that in his new project he is working on the assignments pretty similar to what he had worked on as part of practical training in C-CAP. Naturally this gave him an added advantage in terms of understanding of data and analysis of the same. As part of the operations team, it was very gratifying for us all to hear the kind words from the batch. The batch remains special in our heart, since they put their faith in us and gave 100% commitment as we walked along the journey.

Congratulations to all our gems that are ready to adorn the teams of these reputed organizations! We have no doubt that you will keep up the learning spirit and build an exemplary professional reputation. All the best!!

About the author – Nikhita Pemgirikar-Pasalkar, a post graduate in healthcare management , is working with CliPLab as a program coordinator in Clinical SAS Programming. She has been a key contributor in design and execution of C-CAP program.

C-CAP Xpress – Same Great Program, Now in a Convenient Pack!

We have no doubt that C-CAP has become a preferred option for graduates aspiring to enter the Clinical Trial Services Industry. With over 70 enrollments in 18 months and 100% placement record for first two batches, C-CAP is here to stay and make a meaningful contribution to the lives of many young aspirants.

The success of C-CAP can be attributed to its thoughtful design and meticulous execution.  The format of the program was designed after a series of brainstorming sessions with programmers, leads and managers working in the industry.  Through such discussions, we identified the skills and exposure areas that have a direct and significant bearing on the productivity and performance in Clinical Trial Analytics projects. Next, we invited experienced professionals in the industry to design and develop the training modules. Further, the sessions are facilitated by professionals who themselves are working in various roles on live projects.

Some of the key competency areas that we have identified and addressed through C-CAP are described in the coming :

1. Clinical Trial Domain Overview: Clinical SAS Programming is not merely writing program to analyze data, it is more about understanding the context and applying intelligence to select the approach for analysis. Intelligence comes from knowledge of the domain. Therefore Domain Overview becomes indispensable for anyone aspiring to succeed in the industry.  
2. Statistics Appreciation: Statistics provides scientific models for analyzing the data to extract reliable conclusions that form the basis of business decisions.  Knowledge and awareness of basic concepts in Statistics is useful even for programmers. It enables them to understand the ‘why’ in the data analysis and be able to interpret the results. The module has been designed keeping in mind that the majority of the participants may not have studied statistics at graduate or post-graduate level.
3. Therapeutic Area – Oncology:  Another factor that can help one leapfrog her/his career in this field is the knowledge of the therapeutic area corresponding to the study project. We have picked Oncology which is one of the most extensively studied therapeutic area. Oncology is also peculiar when it comes to treatment of endpoints.  A training module on this topic delivered by a veteran can definitely give the candidates an edge over others trying to get on to a project in Oncology.  We are also planning to add courses on a few other therapeutic areas in future.
4. CDISC Standards: The CDISC open data standards have been developed collaboratively by global volunteers to improve the quality, efficiency and cost effectiveness of clinical research processes from protocol through analysis and reporting. The standards facilitate transfer of data and information in Clinical Research across the organization.  As the standards are adopted / being adopted by most of the global pharmaceutical companies,  it is imperative to have practical knowledge of these standards. As part of C-CAP, we have developed theory and practical training in two of the CDISC standards – SDTM and ADaM.
5. Practical Assignments: Apart from studying the topics explained above, the participants also get a chance to work on a set of assignments in data analysis and validation using SAS^®. The intent is to give the participants a flavor of the modular tasks that they will be asked to undertake at their first job.  The assignments are conducted in a simulated environment that goes closest to the actual project situation.

The stupendous success of C-CAP has inspired us to work further to build a model that will benefit an even wider group of aspirants. Yes, we have bundled the best of C-CAP and packaged it in a convenient format so that you can upgrade your skills without leaving your town. The program, named as C-CAP Xpress aims at providing the candidates with knowledge of essential topics and relevant practical training in the field.  In this guided program, the theoretical sessions are delivered through online learning, while the practical assignments can be taken by accessing our server remotely. Besides, the candidate has access to several clarification sessions with our experienced faculty members. The tentative course structure is as below.

eLearning sessions will be available through our eLearning portal – lms.cliplab.co.in

Apart from the aspiration to make a career in Clinical Programming, Proficiency in SAS Programming language is another pre-requisite to enroll to C-CAP Xpress. Getting the vital skills to foray into Clinical SAS programming has never been so easy. We hope this latest offering will enable us to help some more aspirants fulfill their dream of a thrilling career.  You are invited to visit the page on the our website to know more about the program.     

Unveiled - A short eLearning course on Oncology in Clinical Trials

Oncology is defined as a medical specialty focusing on the study, diagnosis and treatment of cancer which can affect people of all ages.  Oncology is one of the largest and most extensively studied therapeutic areas in clinical research.  A tremendous amount of research (especially in the past decade) conducted on all aspects of oncology including cell biology, radiation therapy, chemotherapy, targeted therapies and supportive care has dramatically changed our understanding of the disease.  Oncology literature is very vast (to say the least); therefore, a basic understanding of the key concepts and terminology pertaining to oncology is critical to a successful career in clinical research.

Clinical Trials in Oncology are somewhat more complicated than other therapeutic areas, with Clinical Endpoint and Adverse Event Reporting being some of the major differentiators.  This is another reason why it becomes important for professionals working on Oncology trials to develop a solid understanding of the therapeutic area. 

While working with CliPLab, as a mentor for C-CAP participants, I realized that there is a large pool of professionals that can benefit from an orientation course in Oncology and other therapeutic areas.  The work in Clinical Trial Services is not just about effective usage of analytical tools such as SAS.  Rather, it is much more about applying the knowledge of the domain to determine the right procedure, approach and the tools to be used for the analysis.  A crisp orientation course on relevant therapeutic areas therefore becomes crucial in order to expect a high level of performance from professionals working on a project in a specific area. With the intent to help working professionals develop a basic understanding of the domain, a short course titled ‘Oncology in Clinical Trials’ has been launched.   

This applied course in oncology will cover several topics from the perspective of conducting, analyzing and interpreting clinical oncology research.  The course is divided into several modules delivered in a logical sequence starting with the introduction to the disease followed by cancer risk factors, cancer diagnosis and staging, basics of cancer treatment, clinical endpoints in cancer, RECIST guidelines and clinical trial designs.  Numerous examples and illustrations are provided throughout the course to facilitate a better understanding of the underlying concepts.  This course offers an ideal platform for candidates seeking to enter a project in Oncology and can be taken at their own convenience through the eLearning portal of CliPLab. Want one more reason? As an inaugural offer, CliPLab is offering 50% discount on the course fee.

Watch for a brief overview of the course content.

Any feedback towards betterment of the course are absolutely welcome.

About the author - The author is a veteran in clinical research with over 15 years of rich and diverse experience in the field.  He has worked extensively in Oncology research and contributed handsomely to the scientific and medical literature of international repute. His profile can be viewed at https://in.linkedin.com/pub/digant-gupta/10/689/b49.