Bioequivalence and Bioavailability Forum

Dear HS,

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.

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

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

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.

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.

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

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

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

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.

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.

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

Best Regards,
Venu