If you're looking for Clinical SAS Interview Questions & Answers for Experienced & Freshers, you are at right place. There are lot of opportunities from many reputed companies in the world. According to research Clinical SAS has a market share of about 16.0%. So, You still have opportunity to move ahead in your career in Clinical SAS. Mindmajix offers advanced Clinical SAS Interview Questions 2019 that helps you in cracking your interview & acquire dream career as Clinical SAS Programmer.
Q1) Compare SAS medical module with Oracle Clinical
|S.No||SAS Clinical||Oracle Clinical|
|1||It is mainly used for statistical analysis||It is mainly used for data management.|
|2||It is built on the idea of converting data management to that of statistical analysis||It is built on the idea of assisting the data management.|
Q2) What is the task of the following in the SAS?
Ans. STDM- It make sure of the data tabulation datasets that FDA needs for the proper submissions based on regulatory
ODM- It is used for transfer of XML based data from one location to another
ICHE9- These are guidelines for statistical Principles following
Q3) In Clinical SAS module, what do you know about the Data Step?
Ans. It is basically a function which is deployed for the purpose of creating an SAS dataset and along with the data dictionary. All the information regarding the variables along with their properties shall be located in the data dictionary.
Q4) What do you know about the Program Data Vector in the SAS memory?
Ans. It is used to represent the logical area. Whenever the SAS consider a database, there is an input buffer which automatically gets created during compilation and holds a record from an extensible file.
Q5) Can you tell what exactly are the data types which are present in the SAS?
There are two data types which are present and they are Numeric and second are Character.
Q6) Is variable comparison possible in SAS approach? Is so, how this can be done?
Ans. Yes, the SAS allow the comparison of the same and the users have no reason to worry about. The fact is there are two functions for this which are NODUP and NODUP key. In the database, the first is considered for the purpose of comparing all the variables whereas the BY variables are compared with the NODUKEY.
Q7) How you can display the content of SAS dataset?
Ans. For this, there are two commands in the module that can be considered and they are PROC Print and content. They also make sure of correct reading of the data without any manipulation. The entire information regarding a dataset can also be made displayed with the help of these functions.
Q8) What are the general phases of clinical trials you are familiar with?
Ans. There are generally four types of clinical trials and they are: Phase 1, Phase 2, Phase 3 and Phase4.
The first phase is when the medicine is to be tested on a limited number of patients to verify its safety standards. In second phase, the medicine tested in first is given to a large group of people to verify the overall effectiveness of the drug. In third level, the overall number of people increased beyond phase second. Also, its effectiveness is monitored largely in this group. The users can then pay close attention on the Phase 4 which is all about the risks associated with the drug.
Q9) What exactly do you know about the Case Report Tabulation?
Ans. It is basically a report which every pharmaceutical company has to submit to the FDA for getting the necessary approvals. The Clinical SAS module is good enough to be trusted for the generation of this report in an effective manner. There are various filters that can be applied and the sections can be nullified with the domain in a very easy manner.
Q10) Imagine a listing with complex needs and a lot of pages, how would validation can be performed in such a scenario?
Ans. Listing first need to be converted into the data sets. This is because it is not possible for the users to perform validation for such a large number of pages. There is a function which can be used for this task in SAS and i.e. PROC
Q11) In SAS, there is often a need to generate graphs, tables and listings for the proper representation of pharmaceutical data, how this task can be accomplished?
Ans. With the help of a function known as PROC REPORT, tasks related to listings can be accomplished very easily. When it comes to table generation, the same can be done with the help of PROC MEANS.
Q12) In the SAS approach, what is the limit in creation of tables daily?
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Ans. It all depends on the task a user is accomplishing and the fact is most tables are difficult to design and adopt. The users have to make sure of doing the things in a rightful manner. The accomplishment of tasks is reliable and easy with some important tables.
Q13) During your past experience with SAS, what are the PROCS which you have used?
Ans. Answer this question based on your knowledge with PROC. This can depend on the projects you handled in the past for the successful accomplishment of tasks.
Q14) Can you name a few important data sets in SAS which can be used for multiple tasks?
Ans. These can be Adverse, Laboratory, Demographic as well as Analysis.
Q15) What are the two formats that FDA accepts when it comes to document submission?
Ans. The format can be PDF or .Xml file. The user needs to update the macros information while doing so in the primary domain for the successful accomplishment of the concerned tasks.
Q16) What ate the benefits of using SAS for medical and clinical applications?
Ans. Well understanding everything about the core clinical applications is almost difficult. The SAS has been provided with some dynamic features which are dedicated for handling complex tasks in this domain. The following are some of the key advantages.
- This tool is quite efficient in performing its tasks
- All the information about the patients, medicines and important sections can be accessed and managed under one go
- It is useful in medicine prescription and management of the same
Q17) How SAS is useful according to you
Ans. IT is basically software package that contains all the information on some relevant key procedures, protocols and Information Technology tools that can be utilized for the accomplishment of various tasks that needs time saving. It provides useful information on the statistical methods as well as on the objectives. There are features and options which are good enough to be considered for the purpose of generating the Clinical Study Report including the relevant figures, summary, as well as subject listing of the concerned protocols. There are also documents that define program variables which are useful in statistical studies.
Q18) What do you know about the Clinical SAS documentation?
Ans. It generally consists of information regarding the comments, header, programmer assigned for the task as well as the key footnotes. This enables the programmers to make sure of reading the clinical terms accurately and reliably. It also assists in diagnosis of the patient in the long run.
Q19) What is the significance of the program header in the SAS?
Ans. It is s useful location every all the information regarding the changes made to the program is stored. The users can check the same to know what sort of changes they have made or the ones that are affecting the prime domain. It is possible to perform the reverse task as per the needs of the users.
Q20) Is it possible to perform the standardization of the FDA in the SAS?
Ans. Yes, it is possible. This can be done with the help of a tabulation model which simply make sure of all the information remain valid and avoidable in the domain. The users are free to derive and modify the results that got generated in the domain.
Q21) What do you know about the validation procedure in SAS?
Ans. When the SAS programs are executed successfully, their outputs need to be validated or verified. This is done generally with the help of Validation Procedure. It is actually the responsibility of the validater to perform this task. The program is declared valid only if the output generated by the programmer remains same as generated by SAS programmer.
Q22) How can transport files be created in the SAS approach?
Ans. This can be done with the help of Proc Copy under the FDA submissions. The users can access upto 5 files at a time and can export the basic files to the transport domain. They can then be converted in the prime domain easily. The labels assigned should not be longer than the 40 bytes and the limit on the character variable is 200 bytes. Upon violation of this limit, the users cannot get the desired results.
Q23) What do you know about the Case Report Form in SAS?
Ans. The case report form is basically a document on which the names of all the variables are written in a defined or an undefined manner. There are certain questions about the CRF and in most of the cases they are addressed with report mechanism. The CRF actually acts as a channel between the CRF and the raw data. A lot of medical programmers and statisticians make use of it.
Q24) What sort of information do you find in the AE dataset and what exactly is the purpose of the same?
Ans. Its stands for Adverse Events. It provides useful information regarding the subject code, subject matter and generally it contain all the relevant codes in the module. In addition o this, it offer users the information of the events as well as on the severity of the same. The required summary of the events can easily be targeted through this approach and this is exactly what that helps users in assuring the overall safety of the drug.
Q25) In Clinical SAS module, what exactly do you know about the basic structure?
Ans. The structure is very simple to understand and implement. It basically consists of two important steps and they are DATA and PROC. The first is used for the purpose of recovering the data and manipulating the same wherever required. On the other hand, the latter is responsible for interpretation of data.
Q26) Suppose you need to run a program in the domain, what would be the style of the Syntax?
Ans. There are some basic elements that user should be careful about. The very first thing is every line must have a semi-colon at its end. There should be a statement that defines the data. The statement or the word should be separated from one another through a space. There should be an Input statement justifying the purpose.
Q27) In SAS, is it possible to clean the data in the system domain and what exactly need to be done for changing the values?
Ans. There are two important commands which remain present in this approach and they are Proc Univariate and Proc Freq. the same can be utilized for finding the deficiencies in the data and can be corrected in a healthy manner.
Q28) What does CDISC stands for?
Ans. CDISC- It stands for Clinical Data Interchange Standards Consortium
Q29) What do you know about the program verification?
Ans. It simply makes sure that all the tables in the domain are accurate and are good enough to be considered for the long run. The overall quality of the SAS program can also be managed through it. Also, the users can simply justify the needs of some special tables. Also, the subsets of the final summary of the tables can be changed through them. The procedure is very much same as to that of macro validation and the very step is always to create a document and then passing it from the input parameters.
Q30) What do you know about ISS and ISE?
Ans. ISS stands for integrated summary of safety and is used for integrating the information about safely from different sources. On the other side ISE stands for Integrated Summary of Efficacy which is responsible for effective submissions of the documents. Both components are critical.
Q31) What is th use of SAS Array?
Ans. A SAS array is used for identifying group of variables that can be processed within a data step. So, once the array is defined the programmer can perform similar tasks for a sequence of related variables known as array elements.
The syntax of array is defined as shown below:
Array array_name (n) Array_values;
Q32) What is treatment emergent and treatment emergent serious adverse events?
Ans. Treatment emergent and Treatment emergent serious adverse events are defined as the situations which occur after the heavy consumption of drug or becoming worsen by the drug ,if the patients already have that effects before the consumption of drugs.
Q33) What do you mean by CDISC standards
Ans. CDISC is an organization which utilizes industry standards for pharmacy industries to send the clinical data to the FDA(Food and Drug Agency).
What is the use of SAS Macro Facility
Ans. The SAS Macro facility is used for:
- Decreasing code repetition.
- Enhancing the control on program execution.
- Reducing Manual interference.
- Establishing Modular mode.
What are the applications of CDISC Standards
Ans. Applications of CDISC Standards are as follows:
- Establishing CRTs to send them to FDA to get NDA
- Analysing, Mapping and Pooling clinical study data.
- With the help of CDISC-SDTM mapping we can create Annotated case report form.
- To continue SAS we can create analysed data sets in CDISC and non-CDISC standards.