7 Reasons to Add a Statistical Consultant to Your Team

Cytel Strategic Consulting| Cytel Consulting |

October 14, 2014

Written by Cytel Consulting

We are often asked how statistical consultants can add value to the clinical development process. What do they contribute to a winning strategy, and how do they optimize business decisions?

Statistical consultants often have decades of experience in multiple aspects of clinical development, including trial design, portfolio optimization, and regulation. Having a broad and yet nuanced feel for the industry enables statistical consultants to generate novel solutions to an array of challenges faced while navigating clinical development.

If you are thinking of hiring a statistical consultant to your team, you should be aware of the many roles that they can play. Here are some of our consultants' favorite recent projects.

Building a clinical development strategy: By evaluating alternative clinical development strategies, we spared our client an unnecessary study, many millions of dollars, and 6-9 months of development time.
Preparing a robust regulatory strategy: Drawing on decades of experience, we successfully guided our client in defending its innovative clinical development strategy in front of regulators.
Balancing competing goals: Working as an integral part of the client team, we devised a customized utility function that combined safety and efficacy objectives to better measure the success of their drug.
Improving information quality: In implementing an adaptive dose-finding study, we helped our client learn more about their asset and maximize its market value.
Providing insightful analysis: By applying signal detection techniques to our client’s data, we developed classification algorithms to help them identify target patient subpopulations.
Securing investment capital: A novel adaptive confirmatory trial helped one of our small biotech clients secure otherwise unavailable funding in a risky therapeutic area.
Delivering with efficiency: Rallying behind a specialty pharmaceutical for its first Phase 3 study, we combined our design and biometrics services to help secure regulatory approval within a year.