Insists We Can Crunch The Numbers Ourselves

We have a filing deadline coming up to extend the shelf life of our lesser-known parenteral product. All the data is in and ready to report, but our statistics department has more pressing issues on their plate—namely a similar report for our flagship product. Their director has flatly rejected efforts by my manager to move us up in the roster and even suggested that we should just do it ourselves, “After all, this is just basic stability stuff,” he insists. We don’t even have a departmental procedure for doing stats in-house.

My tech-wiz colleague who is very good at excel spreadsheets insists that he can accomplish everything I need for the report, he just needs a few days to watch some YouTubes and he’s even going to use AI to help generate some of the tricky coding. I don’t trust this approach and am not comfortable verifying the outputs, but we don’t seem to have much choice. Is it OK to generate this report without having a procedure dictating the contents and statistical strategies? Even if it is, this is going into a filing and seems like we’re a very high compliance risk to take—don’t we need some statistical certification to verify the outputs and confirm they are sound?

Short answer: Yes and No. Longer answer: It is OK generate the report like this, but you do need a procedure ASAP, or have the statistics department link theirs to your area somehow and get on their training roster. Not having a formal stats certification doesn’t mean your verification and confirmation will be invalid, just maybe a little less trustworthy.