At Statistics Collaborative, we specialize in working with clients interested in ongoing dialogue between their own field and statistics. Our experience comes from decades of cooperating with researchers on projects of a wide range of complexity.
Learn more below about getting started with SCI, our approach to developing client relationships, DMC committee-specific topics, and what to expect throughout our partnership.
If you wish to speak to a specific statistician at SCI, just send an email or call 202.247.9700 and ask for that person. If you don’t know any of us, submit a request here.
Each project at SCI has a project manager-usually a senior-level statistician-who oversees the day-to-day activities of the project. Project teams have at least one statistician and a project assistant responsible for the administrative needs of the project. Large teams may also have additional statisticians, programmers, and administrative staff. For some very large projects, we designate a second project manager as a back-up to the main project manager.
SCI believes stable project teams are important for maintaining consistently high-quality work throughout the lifetime of the project. Therefore, we try to keep the same project manager involved for the life of the project. To the extent feasible, we keep the teams constant as well.
Regardless of the size of the project team, SCI’s communication procedures ensure every project team member has the information necessary to work efficiently.
If your project is small, your point of contact will be the primary statistician. For projects that involve a team from SCI, the project manager will generally be your point of contact. Our senior-level statisticians travel frequently, so if you have an urgent need for statistical advice, other staff can usually step in.
SCI works with our clients throughout the life cycle of study development. Our statisticians provide an experienced perspective on the entire process, starting from the initial stages of defining endpoints, writing protocols, calculating sample sizes, designing case report forms, and continuing on to the later phases of analysis, interpretation, and regulatory submission.
We are most effective collaborators when we begin working with the study team early in the process, but we also have considerable experience joining project teams during an ongoing study or after an unsuccessful regulatory submission.
We recommend forming the committee and holding an organizational meeting to establish operating procedures prior to enrolling the first participant.
SCI often reviews analyses performed by others. We may simply review the methodology to see if it is appropriate for the question asked and the data collected.
We may suggest other methods of analysis that take into consideration the disease under study, the conduct of the trial, or issues with the data. In many cases, clients provide us with the data and we perform our own analyses and write a summary report.
We believe it is important for the statisticians involved in the final statistical analysis of a trial to be the primary statistical authors of the analysis plan. To ensure the accuracy and interpretability of the results, those involved in the analyses should be involved in preparing the plan.
If, however, the company or contracted organization doing the final analysis would like SCI to provide an additional statistical review of the analysis plan, SCI is able to provide that support.
We encourage our clients to include SCI at their trials’ organizational and investigator meetings. SCI prefers to join projects as early as possible so that we can provide input into the protocol, analysis plan, and charter.
DMCs typically express their opinions about their review process at organizational meetings; therefore, we recommend that the statisticians from SCI who will be presenting to the DMC participate in these discussions.
SCI believes that the role of independent reporting statistician should be just that, independent. The independence of the reporting group is compromised if that group also provides a member to serve on the DMC.
A DMC statistician has the authority to request additional analyses while a trial is ongoing. At SCI, we see this as a conflict of interest if the DMC statistician has the ability to generate additional work that his or her organization will ultimately perform.
Interim data are inherently messy and quite different than final, locked data. Thus, programming analyses for interim DMC reporting is inherently different from programming analyses for the end of study. At SCI, we believe that it is best to keep these activities separated; however, in some cases, we will do both.
Yes. We have worked with many clients on the final analysis for NDA, BLA, and medical device submissions to the FDA. We are familiar with CDISC data standards and have experience programming ADaM datasets along with the required data documentation. We do not program SDTM datasets; however, we have worked with clients to identify organizations who are able to fulfill that role.
We are always seeking talented and motivated statisticians and research support staff to join our team. Please see our career opportunities page for further details on open positions. We encourage you to apply if you think you would be a good fit at SCI.
To contact SCI about a potential project, please call us at 202.247.9700 or click below.
Statistics Collaborative is experencing a business interruption due to circumstances beyond our control. Please call our main company phone number for details and updates.