The problem
The decisions that determine whether a study can demonstrate anything are made at design: the endpoint, the effect size assumed, the power, the population definition. By the time the data exists, those are fixed.
Under-powering is the expensive version of this. A study runs to completion, costs what it costs, and produces a result nobody can act on. The statistical mistake was made two years earlier in a conversation the statistician was not part of.
So we push to be involved at protocol design. It is the cheapest hour of statistical time you will ever buy.
Tell us the problem. A specialist replies, not a form robot.
What we do
Endpoint selection, effect size assumptions and power, argued rather than assumed.
Pre-specified so regulators accept the analysis rather than question it.
Schedules and stratification designed for the study, not copied from the last one.
Adaptive designs and DSMB support with the alpha spending planned.
SDTM and ADaM datasets, define files and reviewer guides.
Tables, listings and figures built for the CSR and the submission.
For consultants
Statisticians and statistical programmers are among the scarcest profiles in the sector and are almost always working. Being known to us matters more here than anywhere.
Proof
The cheapest hour of statistical time you will ever buy.
Client testimonials for this discipline are being collected and will appear here once approved in writing by the clients concerned.
Questions
Yes, though we will be candid about what can still be changed. Analyses can be tightened; a design decision usually cannot be undone.
Both. SAS remains the submission default in most cases; R is increasingly used alongside it. We screen for the one you actually need.
Yes, and it goes better when the people answering wrote the original plan.
Almost always, which is why these roles attract strong candidates nationally.
SAP authoring and analysis packages work as fixed scope. Ongoing programming support is time and materials.
Related
Hiring for it, or looking for the work. Either conversation is welcome.