SAS Clinical Interview QUESTIONS and ANSWERS

Q)What is the therapeutic area you worked earlier?

There are so many diff. therapeutic areas a pharmaceutical company can work on and few of

them include, anti-viral (HIV), Alzheimer’s, Respiratory, Oncology, Metabolic Disorders (AntiDiabetic),

Neurological, Cardiovascular. Few more of them, include…

Central nervous system

Neurology

Gastroenterology

Ophthalmology

Orthopedics and pain control

Pulmonary

Vaccines

Dermatology

Gene therapy

Immunology etc

Q)What are your responsibilities?

Some of them include; not necessarily all of them….

· Extracting the data from various internal and external database (Oracle, DB2, Excel

spreadsheets) using SAS/ACCESS, SAS/INPUT.

· Developing programs in SAS Base for converting the Oracle Data for a phase II study into SAS

datasets using SQL Pass through facility and Libname facility.

· Creating and deriving the datasets, listings and summary tables for Phase-I and Phase-II of

clinical trials.

· Developing the SAS programs for listings & tables for data review & presentation including adhoc

reports, CRTs as per CDISC, patients listing mapping of safety database and safety tables.

· Involved in mapping, pooling and analysis of clinical study data for safety.

· Using the Base SAS (MEANS, FREQ, SUMMARY, TABULATE, REPORT etc) and SAS/STAT

procedures (REG, GLM, ANOVA, and UNIVARIATE etc.) for summarization, Cross-Tabulations

and statistical analysis purposes.

· Developing the Macros at various instances for automating listings and graphing of clinical

data for analysis.

· Validating and QC of the efficacy and safety tables.

· Creating the Ad hoc reports using the SAS procedures and used ODS statements and PROC

TEMPLATE to generate different output formats like HTML, PDF and excel to view them in the

web browser.

· Performing data extraction from various repositories and pre-process data when applicable.

· Creating the Statistical reports using Proc Report, Data _null_ and SAS Macro.

· Analyzing the data according to the Statistical Analysis Plan (SAP).

· Generating the demographic tables, adverse events and serious adverse events reports.

 Q)Can you tell me something about your last project study design?

If the interviewer asked you this question, then you need to tell that your current project is on a

phase-1 study (or phase-2/Phase-3). You also need to tell about the name of the drug and the

therapeutic area of it. Here are some more details you need to lay down in front of him…

a) Is it a single blinded or double-blinded study?

b) Is it a randomized or non-randomized study?

c) How many patients are enrolled.

d) Safety parameters only (if it is a phase-1)

e) Safety and efficacy parameters if the study is either Phase-2,3or 4.

Q)How many subjects were there?

Subjects are nothing but the patients involved in the clinical study.

Answer to this question depends on the type of the study you have involved in.

If the study is phase1 answer should be approx. between 30-100.

If the study is phase2 answer should be approx. between 100-1000.

If the study is phase3 answer should be approx. between 1000-5000.

Q)How many analyzed data sets did you create?

Again it depends on the study and the safety and efficacy parameters that are need to

determined from the study. Approx. 20-30 datasets is required for a study to get analyzed for

the safety and efficacy parameters. Here is some ex. of the datasets.

DM (Demographics), MH (Medical History), AE (Adverse Events), PE (Physical Education), EG

(ECG), VS (Vital Signs), CM (Concomitant Medication), LB (Laboratory), QS (Questionnaire), IE

(Inclusion and Exclusion), DS (Disposition), DT (Death), XT, SV, SC (Subject Characteristics),

CO (Comments), EX (Exposure), PC, PP, TI (Therapeutic Intervention), SUPPCM, SUPPEX,

SUPPLB, SUPPMH, SUPPXT, SUPPEG, etc.