Introduction of a new drug, treatment option or medical device to the healthcare industry for
public use is a higher-risk enterprise. Clinical trials are systematic studies conducted by researchers to
find out if a new drug or treatment procedure or a medical device is safe and effective in people. Having
shown the efficacy and safety of the product the manufacturers with clinical trial data move to the
regulatory authority, US- FDA to get approval for marketing the products. Further keeping the safety of
the patients in mind the manufacturers and marketing authorities are directed by regulatory authorities
to conduct their Phase 4 (Post Marketing Surveillance) clinical trial of their products in practical
population throughout the life cycle of the products. If the product fails in clinical trial studies, it incurs
great loss to the manufacturer. Hence, the clinical trials and their results are essentially the key factors
that determine the market value and life of the product.
ROLE OF STATISTICS IN PHARMACEUTICAL INDUSTRY
The use of statistical tools and concepts in drug discovery, drug testing, manufacturing, and
marketing has shown tremendous growth in Pharma and Biotech sectors, creating career opportunities
for statisticians, biostatisticians, and clinical statisticians. Clinical trial studies generate a pool of data
that has to be carefully analyzed and assessed to draw an inference. This inference is important to write
a summary of the clinical trial and here starts the role of clinical statistical programmer. To know the
importance of Clinical Statistical Programmer it is important to know about data flow in clinical trials.
WORKFLOW IN CLINICAL TRIAL DATA ANALYSIS
After conducting clinical trials, the Clinical Data Management (CDM) team collects the data from
different clinical trial sites, manages the data, and securely enters the data into the Clinical database.
The data includes demographic information, disease condition, diagnosis, treatments taken, lab tests,
etc.The Clinical Statistical Programmer / Clinical SAS Programmer collects the clinical trial data from the
database, analyzes, summarizes, and draws inferences in the form of graphs, tables, and listings. For
generating this inference Clinical Statistical Programmer uses SAS.
The inferences and reports prepared by Clinical Statistical Programmer are submitted to
Clinicians and Statisticians to write study reports. The study reports are then forwarded to US-FDA for
New Drug Application (NDA). FDA accepts only SAS data.
WHAT IS SAS?
It is a software system developed by the SAS Institute, for data analysis,report writing and is
widely used in the banking, insurance, and healthcare sectors. SAS is also used by Pharmaceutical,
Biotech, and Clinical Research Organizations in clinical trial data analysis.
IMPORTANCE OF CLINICAL SAS PROGRAMMER
1. The knowledge and skills of a competent Clinical SAS Programmer helps to uncover many
hidden issues and are helpful to the clinicians to note down the new outcomes from the trials
2. The SAS Programmer also helps the clinical research to achieve great speed and efficiency
3. Helps the organization to meet its business goals, enhance strategic performance, generate
great revenue, and most importantly control the cost of the studies.
Thus, the role of clinical SAS Programmers in clinical researches is inevitable.
DUTIES OF CLINICAL SAS PROGRAMMER
1. Extract data from various clinical databases for preparing study reports
2. Utilize the SAS programming skills with the protocol team and write programs to create table
lists and graphs – that show the specific information the company wants to focus on
3. Write macros to simplify the data set, making the database easier to search and locate
information
4. Analyze data and statistics to find market trends and other business-relevant information
5. Prepare a summary of the study and perform quality control on final reports
6. Work in tandem with the data management team and statistics leads.
REQUIRED EDUCATION QUALIFICATION
1. B. Pharm, M.Pharm and Pharm D
2. Life science graduates
3. Bioinformatics graduates
4. BE, B.Tech (Biotechnology / Bioinformatics/ Computer Science/ EC)
5. MCA, BCA
6. Medical graduates, Dentist, BHMS and BAMS.
REQUIRED SKILLSETS
1. SAS, SAS Macro & Clinical Statistical Programming
2. Eye on minute details and good analytical thinking.
3. Good communication skills
4. Time management skills to priorities work tasks.
CAREER PATH IN CLINICAL SAS PROGRAMMER
Depending on the size of the company the role of clinical SAS programmer varies and in general the
following grading system can be seen in clinical SAS programmer career.
- Statistical Programmer Trainee
- Associate Statistical Programmer
- Statistical Programmer I
- Statistical Programmer II
- Senior Statistical Programmer I
- Senior Statistical Programmer II
- Team Lead / Statistical Data Scientist
- Manager
- Senior Manager
- Associate director
- Director
- Senior Director
- Vice president
SALARY
From 4 Lacs (Freshers) to more than 15 lakhs per annum (Experienced)
MAJOR RECRUITERS
1. Pharma Industry
2. Biotech Companies
3. Clinical Research Organizations’(CROs) and IT Companies likeIQVIA, Covance, Accenture,
Paraxel, TCS, HCL
JOB PREFERENCES IN INDIA
Clinical SAS Programmer is one of the challenging and rewarding jobs. Evidently, the Indian
clinical trial market size is increasing significantly since 2000 and is expected to reach USD 3.15 billion by
2025. The Covid pandemic has prompted more than 400 registered clinical trials in India in 2019-2020.
Globalization of clinical trials, improved regulatory system, smooth law path, low cost of doing
business in India, availability of expert researches, large patient pool- all of these cumulatively makes
India a favorite hub for carrying out clinical trials. MNC Pharma giants like Novartis, AstraZeneca,
GlaxoSmithKline (GSK), Aventis, Eli Lilly, and also Indian companies like Dr. Reddy's, Nicholas Piramal,
Cipla, and Lupin are conducting clinical trials in India.
BE PREPARED TO EMBRACE THE OPPORTUNITY
Undoubtedly, in near future, the clinical research area will expand exponentially and the gap
between the clinical trial data collection and report writing can be fulfilled only by a competent, skilled,
and certified Clinical SAS Professional. Pharmacy graduates being aware of medical terminology,
disease conditions, clinical trial ethics & procedures, and drug discovery process are more preferable to
life science graduates. MNC companies prefer Post Graduate Pharmacy candidates and Pharm D
candidates to be their clinical SAS programmers.
Merely degree education will not impart knowledge in SAS Programming. As recruiters also
prefer a Certified Clinical SAS Programmer undertaking a certificate course in Clinical SAS Programming
surely makes a big difference in placement.