Bioequivalence and Bioavailability Forum

Dear Venu,

I am tempted to answer your queries out of curiosity!!

❝ Being a biostatistician in this field from past 3 years, I have seen recently an ample of growing opportunities in the sas programming in Clinical Trials and BA/BE studies.

Correct assessment.

❝ I like doing SAS programming and learning new techniques, procedures and updating the skills every day.

You are a good learner and will be bright star one day in this field if you continue to do what you are doing.

❝ Many companies have biostatistician but they are not skilled in the field of sas programming.

Again correct assessment of the ground realities.

❝ They do the analysis from SAS, WinNonlin and other statistical softwares and generate tables, figures and listings manually i.e. in MS Excel and MS Word typing and entering the results and making reports.

This is the standard practice in most of the CROs and pharmaceutical companies.

❝ But I always used to generate the tables, figures and listings required in the Clinical Trials and BA/BE studies by SAS programming and preparing the templates which can be used in future studies.

You are really smart!!

❝ My 1st question is:- Is it mandatory to do sas programming in Clinical trials and BA/BE studies?

No its not. You can do all the calculations in a piece of paper using calculator if you are good biostatistician. But, SAS is hard to buy and easy to use. The choice is yours.

❝ My 2nd question is:- Does any guidelines give some relevant information on sas programming?

You mean BABE studies?. There is a SAS program in the appendix of FDA guideline on Statistical issues in BABE studies. The book supplied by SAS to users called Statistical analysis of clinical trial data is good. Don't look for guidelines for everything. Look for solutions, use them in your milieu and justify its use.

❝ My 3rd question is:- Can the FDA make some principles on SAS programming in Clinical Trials and BA/BE studies?

Oops its hot!!!

❝ I have read in the many guidelines that for the role and responsibilities of a biostatistician an equally qualified/trained/experienced are required in the Clinical Trials and BA/BE studies.

It's safe to have sombody like that. If you dont.. you know what to do...

❝ My 4nd question is:- Can a non-statistician (for eg:- B.Com., B.A., M.Com, MBA) do the statistical analysis, generate tables, figures and listings, SAS programming and preparation of statistical report?

❝ I know the answer to this 4 question and the answer is NO.

Bravo!!! correct answer. You get marks 100 out of 100 for this sixer.

❝ But I still want to reconfirm, since I have seen these situations in some CROs.

There are some funny CROs still do that. One CRO gave the offer of Head-Biostatistics job to my secretary who is a B.com. funny ah!!