Scott Mollan
Associate Director, Biostatistics
Scott Mollan
Associate Director, Biostatistics
Scott Mollan has over 17 years of experience in clinical and non-clinical statistics across the CRO & pharmaceutical industry. As Associate Director, Biostatistics, Mr. Mollan provides day to day technical and operational leadership to project teams and ensures success by disseminating industry trends and implementing best practices.
During his career, Mr. Mollan has been responsible for all aspects of statistical support including study design, creation of statistical analysis plans, analysis execution, and results interpretation & communication. Having led studies of all phases (pilot, pivotal, post-market, phases I-IV) and assisting clients during both the pre-submission phase and FDA approval via the NDA/PMA process (2 NDAs/10 PMAs), he has a wealth of experience to draw upon to support clients.
Mr. Mollan has been involved in a wide range of therapeutic areas such as: cardiovascular, dental, in vitro diagnostics, joint replacements, medical imaging, NASH, oncology, osteoarthritis, pulmonary, women’s health, and wound healing. Armed with graduate degrees in business and statistics, Mr. Mollan has been able to leverage his understanding of the clinical trial process via this diverse range of indications to publish on the medical device trial process, lung cancer diagnostics, and women’s health while similarly offering industry presentations on missing data analysis strategies and the use of adaptive trial designs within medical devices studies.
Why Biostatistics?
“As the famous statistician John Tukey once said, “The best thing about being a statistician is that you get to play in everyone’s backyard.” Taking this to heart, I find it incredibly rewarding to have the opportunity to apply my analytical skill set to many areas of clinical research. If I can help advance medical understanding, bring new treatment options to market, and improve the quality of life for patients, then I have had a great day.”
This is what drives Scott:
“Patients. I think of family members & others like them who are waiting for medical advancements to help manage and/or defeat their diseases. I do not want to let these people down and thinking of them pushes me forward.”
Content by Scott Mollan
Blog Post
Statistical Challenges with Site Enrollment in Clinical Trials
Did you know that insufficient enrollment is the leading cause for clinical trials being halted? Study sponsors rightly embrace those sites which are high performing as they give a study the best opportunity to meet its enrollment targets. However, is it possible for there to be overreliance on these high enrolling sites? Unfortunately, the answer is yes.
Blog Post
How Many Strata can my Randomized Clinical Trial have?
When running a randomized clinical trial, if there are factors which are known during the study design phase to influence study results, it may be advantageous to utilize a stratified randomization which ensures each prognostic factor is balanced between treatment arms.
Blog Post
Drug Development & Estimands – A Framework that Evolves with Product Knowledge
Since the introduction of estimands, the answer to “Why are estimands necessary?” has remained constant – to allow for clearer communication about benefits/risks of a potential treatment to the relevant stakeholders. However, as illustrated in this blog, the number of questions as to how & when to use them has grown considerably.
Webinar
Leveraging Interim Analyses to Optimize Late Phase Clinical Trial Decision Making
Interim analyses (IA) are an essential part of clinical trials that—as a form of adaptive design—can help sponsors make informed decisions about whether to keep a trial going or discontinue it entirely. Join Rho’s Brett Gordon, Ben Vaughn, and Scott Mollan for this Q&A roundtable that will cover some of the most frequently asked questions they get from pharma companies about interim analysis.
Blog Post
Clinical Trial Analysis Considerations for a Post-Hoc Overall Survival Endpoint
When analyzing overall survival in a post-hoc manner sponsors need to carefully consider the types of analyses to present and have a thorough understanding of both the regulatory precedent and market landscape which their product will enter.
Blog Post
How to Place Overall Survival Results into a Proper Benefit-Risk Framework
Overall survival (OS) is both an important efficacy & safety endpoint for oncology trials. Often when study results are submitted for regulatory consideration, OS results are often “immature”/still in their early stages which makes them difficult to evaluate. Understanding how to place these results into a proper benefit-risk framework for consideration is therefore important when assessing a potential treatment’s viability.