Biostatistical Consulting Services For

Late-Phase Clinical Research

and Data Safety Monitoring Boards

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

I provide independent biostatistical expertise, with more than 40 years of experience supporting late-phase clinical research, observational studies, and Data Safety Monitoring Boards.

My work focuses on:

• • Direct collaboration with a highly experienced biostatistician 
  • An independent perspective with clear, practical input on study design, analysis and interpretation 
  • Extensive experience with late-phase and observational research
  • Independent biostatistician for Data Safety Monitoring Boards 

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:

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

In addition, 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 activities and associations include:

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

 

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 speaking with you!