Biostatistical Consulting Services For Late Phase

Observational and Randomized Clinical Studies

and Data Safety Monitoring Boards

Hi, I am Marc Schwartz, Founder/CEO of MS Biostatistics, LLC.

Over the course of more than 40 years in applied biostatistics, I have contributed to a wide range of clinical trial and observational research efforts across industry and academic settings. My work has focused on providing clear, practical statistical input to support study design, analysis, and interpretation.

Throughout my professional journey, I have engaged in collaborative endeavors with:

• • Pharmaceutical Companies
  • Medical Device Companies
  • Clinical Research Organizations (CROs)
  • Investigator Initiated Studies (IIT)
  • Medical and Surgical Specialty Societies and Associations

These collaborations have resulted in over 150 peer-reviewed manuscripts, podium presentations and posters, across numerous clinical specialty domains, including, but not limited to:

• • Cardiac Surgery
  • Cardiology
  • Lymphedema
  • Neurology
  • Oncology
  • Ophthalmology 
  • Orthopedics
  • Peripheral Vascular Disease
  • Urology

In addition to supporting publication and presentation related work as above, I have over 20 years of experience serving as the independent biostatistician for Data Safety Monitoring Boards (DSMBs), also known as Data Monitoring Committees (DMCs), that provide oversight of regulatory submissions for pharmaceutical and medical device clinical trials. In this role, I provide collaborative expertise to the physician subject matter experts on the Board, to enable informed discussions regarding study status, reviews of interim safety and efficacy results, study protocol compliance and operational integrity issues. These reviews can result in recommendations to the sponsor with respect to study conduct, modifications to the study protocol and the evaluation of pre-specified study stopping rules for safety, efficacy and futility.

More generally, my professional associations and activities include:

• The American Statistical Association
• The Society for Clinical Trials
• The R Foundation for Statistical Computing and Contributor to R
• Author/Maintainer of the WriteXLS and BI Packages for R
• Co-author of "R: Regulatory Compliance and Validation Issues: A Guidance Document for the Use of R in Regulated Clinical Trial Environments."
• Editorial Board - The Journal of Statistical Software (Past)
• My ResearchGate profile that contains a subset of the publications and presentations that I have been involved with

If you are in need of services that are not specifically mentioned here, please contact me so that we can discuss your requirements in detail.

I look forward to the opportunity to speak with you!