Preparing clinical study data and conducting statistical analyses are essential components of what we do at Statistics Collaborative, Inc. (SCI). Our staff of programmers and statisticians has many years of experience using commercially validated software, ranging from sample size calculations at the beginning of a study to sensitivity analyses following a regulatory submission, and all stages in between.
Much of our programming is done in SAS®, making use of our proprietary macros for version control and archiving of log and output files for each run. Our programs are independently reviewed by a more senior programmer or statistician using validation approaches customized to reflect the complexity of each program. Beyond SAS®, our programmers are also familiar with S-Plus®/R, nQuery Advisor®, PASS®, CART®, and other specialized statistical packages. In addition, we routinely use coding dictionaries (MedDRA, WHOdrug, and ICD9) to summarized adverse events and concomitant medications.
More specialized programming capabilities include simulations for study design, bootstrapping, randomization tests, and other non-standard statistical analyses.