Clinical SAS Programmer -EpochSASTraining
Largest and Oldest SAS Training Institute
http://epochresearchinstitute.com
+91 79 4032 7000| +91 80 9575 7700|+91 99404 52792
Whats-app: +91 99789 95178 | +91 63608 17936
INTRODUCTION
In the pharmaceutical biostatistics combined with knowledge of SAS® can lead to a challenging and rewarding career that also positively impacts and transforms patients’ lives.
INDUSTRY OVERVIEW
PRODUCT DEVELOPMENT LIFE CYCLE
The product development life cycle of a new drug, biologic or device is a long and expensive process. It typically takes 10-15 years - and costs millions if not billions of dollars - to bring a new product to market. The entire life cycle is complex but can be broken down into three broad stages of Discovery/Research, Clinical Development, and Commercialization.
In the Discovery/Research stage for drugs and biologics, scientists in the lab identify, design, and test thousands of molecules in the search for a promising compound which can potentially treat or prevent a specific disease or condition. Once a candidate compound and a target disease or condition are identified, the compound undergoes further non-clinical testing.Testing includes laboratory experiments and animal studies in which the potential therapeutic effects, safety, and toxicity of the compound are studied and assessed to determine if the compound can proceed into the Clinical Development stage.
In the Clinical Development stage, a research study called a clinical trial is used to expose volunteer human subjects to the compound or device to determine if it is safe and effective. A clinical trial is also commonly used to compare treatments to determine which is better. There are 4 phases of clinical trials, known as Phases I-IV. In Phase I studies, a small number of usually less than one hundred healthy volunteers are administered the compound. These studies are used to assess a compound’s safety, tolerability, and pharmacologic profile. Phase II studies are used to study the safety and efficacy or effectiveness of the compound in subjects having a specific disease or condition. Typically, Phase II studies are larger, enrolling one to two hundred subjects, and the studies are run under very controlled conditions. Phase III studies are referred to as pivotal studies and are also used to assess safety and efficacy in a specific target population. These studies are much larger, enrolling several hundred to thousands of subjects. Upon successful completion of the Phase I-III studies, all of the information from the preclinical studies and clinical trials is compiled into a package of information called a New Drug Application or NDA. The NDA is submitted to various regulatory agencies such as the Food and Drug Administration (FDA) in the US or the European Medicines Agency (EMEA) for review and recommendation. If approval of the NDA is granted by these regulatory agencies, the product moves into the Commercialization stage.
In the Commercialization stage, the manufacturer is allowed to market and sell its product in the countries where regulatory approval has been granted. Once marketed, the manufacturer must continue to monitor and collect information about its product and provide updates to the regulatory agencies regarding the safety of its product. Phase IV studies are initiated in this stage. These are used to continue to collect safety and efficacy information on product usage, to test the use of the product for new indications, and to study cost effectiveness and quality of life issues associated with the product.
In the product development life cycle, the use of statistics is seen in all 3 stages. In the Discovery/Research stage, statistical methodology is used to analyze data collected from the laboratory experiments and animal studies. Experimental design methods can be applied to possibly reduce the sample size and the number of experiments or studies needed, thus helping to control costs. Similarly, in the Clinical Development and Commercialization stages, statistical methods are used to properly plan and execute the clinical trials as well as analyze the data collected in these studies. Lastly, in product manufacturing, statistical process control or SPC is used to measure and control variability and ensure product quality.
All of the aforementioned activities generate reams of data, all of which must be collected and stored, manipulated and combined, analyzed and summarized in some meaningful fashion. Programming, in conjunction with statistical software, is used to accomplish these tasks. The FDA does not require or specify the use of any particular programming language or statistical software. However, SAS was adopted by the industry many years ago and a majority of biopharmaceutical and medical device companies currently use SAS, particularly in working with their clinical trials data.
The conduct and execution of a clinical trial is described in a document called a clinical protocol. The protocol is a written plan which describes the objectives of the study, types of subjects who will be enrolled, schedules of tests and procedures which will be performed, drugs and dosages which will be administered, length of the study, and outcomes that will be measured. The clinical trial is conducted at one or more clinical study sites chosen by the company conducting the clinical trial, also known as the study sponsor. Clinical study sites may include doctor’s offices, hospitals, clinics, or outpatient facilities.
Some of the key personnel involved in writing the protocol and conducting the clinical trial include the clinical program manager who serves as a project manager and may have oversight over multiple clinical trials; the medical monitor, a physician who provides medical guidance in the design, execution, and reporting of the clinical trial; the clinical research associate or CRA who is responsible for monitoring the execution of the clinical trial at the clinical study site; the medical writer who compiles and prepares clinical documents, particularly those to be filed with regulatory agencies; the data manager who oversees the design and maintenance of the data base where the clinical trials data are stored; the biostatistician who provides statistical expertise in the clinical trial design and analysis of the data; and the clinical programmer who generates the tables, listings, and figures needed for the analysis and reporting of the study.
Once a clinical trial is completed, a report which is called a Clinical Study Report or CSR presenting the results, findings, and conclusions is prepared and written.
BIOSTATISTICIAN/STATISTICIAN – RESPONSIBILITIES
The clinical biostatistician/statistician has the primary responsibility to provide statistical expertise in the design of the clinical trial and in the analysis and associated interpretation of the study data. Other key responsibilities may include writing the statistical methodology section of the study protocol which describes the statistical analyses which are used in the study design and analysis of the clinical trial data collected, determining the correct sample size or number of subjects needed to achieve statistical significance in the context of the study hypothesis being tested, generating the study randomization schedule which is used to randomly assign subjects in the clinical trial to the different treatment groups in the study, writing the Statistical Analysis Plan or SAP which is a document that provides more specific details for performing the statistical analyses described in the study protocol, defining the output
(tables, listings, and figures) needed for the analysis and reporting of the study, reviewing the statistical output and defining any additional ad-hoc output needed, and writing the statistical section of the Clinical Study Report. A more experienced clinical biostatistician/statistician will also serve as the statistical point of contact in meetings, consultations or discussions with the FDA.
The clinical biostatistician/statistician may also review the Case Report Forms (CRFs) which are the instruments used to collect the clinical trials data as well as the data base structures where the data will be stored. A clinical biostatistician/statistician with programming expertise may also write some of the SAS code to perform the statistical analyses, create analysis data sets containing derived variables, or write programming code to validate output produced by others.
Other related jobs in the biopharmaceutical industry for a biostatistician/statistician include opportunities in nonclinical, working with scientists to properly design and analyze preclinical laboratory experiments and animal studies; translational medicine, applying correct statistical methods to ensure that the translational process of a basic laboratory discovery to the clinic for the diagnosis, treatment or prevention of a specific disease is accurate and reliable; pharmacokinetics, providing statistical support for the exploration, analysis, presentation, and interpretation of pharmacokinetic (PK) and phrmacodynamic (PD) data; outcomes research and pharmacoeconomics, applying statistical methodology to determine which treatments work best for which types of patients and to compare the value of one drug or therapy to another.
CLINICAL PROGRAMMER – RESPONSIBILITIES
The clinical programmer has the primary responsibility of writing programs in SAS to generate the output (tables, listings, and figures) needed for the analysis and reporting of the clinical study. Other key responsibilities include reviewing the Case Report Forms (CRFs) and the data base structures where the data will be stored, writing programs known as edit checks to generate output that is used for data cleaning and data review, creating standardized analysis code to be used by all programmers working on the same study, writing programs to perform the statistical analyses and generate ad-hoc output, creating analysis data sets containing derived variables, and writing programs to validate output and data sets produced by others.
In some companies, a distinction is made between clinical programmers and statistical programmers. In these companies, statistical programmers generate all the necessary statistical output needed for the study and work closely with the project statisticians, while clinical programmers work exclusively on non-statistical programming tasks.
Other related roles for clinical programmers include data standards programmer which entails creating data sets in a standardized structure and format for submission to the FDA, and pharmacokinetics programmer which involves working with pharmacologists to produce the data sets needed for performing clinical pharmacokinetics analyses.
CONCLUSION
For those looking to move their career in the biostatistical direction, there are time and cost considerations that should be taken into account before pursuing any of the educational options presented in this paper. However, future job prospects appear to be good as demand for people with skills in both biostatistics and SAS programming remains high. In 2012, the Bureau of Labor Statistics reported that job growth in these professions was projected to be more than 20% in coming years. In summary, if you are looking for the opportunity to develop and expand your career while collaborating with other talented individuals in positively impacting health for everyone, consider a career in biostatistics and clinical SAS programming.
Clinical SAS Programmer -EpochSASTraining
Largest and Oldest SAS Training Institute
http://epochresearchinstitute.com
+91 79 4032 7000| +91 80 9575 7700|+91 99404 52792
Whats-app: +91 99789 95178 | +91 63608 17936
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