Independent Biostatistical Consulting Services For Late-Phase Clinical Research and Data and Safety Monitoring Boards
I am Marc Schwartz, Founder and CEO of MS Biostatistics, LLC. I provide independent biostatistical expertise with more than 40 years of experience in clinical research, including late-phase and observational studies and service as an independent biostatistician for Data and Safety Monitoring Boards (DSMBs), also known as Data Monitoring Committees (DMCs).
My statistical consulting services for late-phase studies are focused on post-approval and/or post-market research involving FDA-approved or FDA-cleared pharmaceuticals and medical devices and are provided outside the context of regulatory submissions.
Separately, I provide independent biostatistical services for DSMBs/DMCs overseeing regulatory-submission clinical trials.
Biostatistical Consulting for Post-Approval & Late-Phase Studies
I collaborate directly with pharmaceutical and medical device sponsors, investigators and study teams on the design, analysis and interpretation of post-approval and post-market clinical research. Services include study design and protocol development, Statistical Analysis Plan (SAP) development, interim and exploratory analyses, post-study analyses and publications, and post-hoc analyses of prior studies.
Learn more about Late-Phase Studies →
Independent DSMB & DMC Biostatistical Services
I have more than 20 years of experience serving as an independent biostatistician for Data and Safety Monitoring Boards (DSMBs) and Data Monitoring Committees (DMCs) overseeing regulatory-submission studies, including Phase II/III pharmaceutical studies conducted under INDs and medical-device studies conducted under IDEs.
In this role, I collaborate with physician subject-matter experts to review interim safety and efficacy results, study enrollment and conduct, protocol compliance, operational integrity, and pre-specified stopping rules for safety, efficacy and futility.
Learn more about DSMB Services →
Why Work With MS Biostatistics?
- Senior-level expertise: More than 40 years of experience in biostatistics and clinical research.
- Direct collaboration: Work directly with an experienced biostatistician.
- Independent perspective: Objective statistical input on study design, analysis and interpretation.
- Clinical research experience: Extensive experience across late-phase, observational and randomized studies.
- DSMB/DMC experience: More than 20 years providing independent biostatistical support for Data and Safety Monitoring Boards.
- Broad clinical experience: Experience across multiple medical and surgical specialties.
Clinical Research Experience
My collaborative research experience includes work with pharmaceutical and medical-device companies, clinical research organizations (CROs), investigator-initiated studies, and medical and surgical specialty societies and associations.
These collaborations have contributed to more than 150 peer-reviewed manuscripts, podium presentations and posters across a broad range of clinical specialties.
Clinical and Therapeutic Areas Include:
- Cardiac Surgery
- Cardiology
- Lymphedema
- Neurology
- Oncology
- Ophthalmology
- Orthopedics
- Peripheral Vascular Disease
- Urology
Selected Publications and Presentations
A subset of the publications and presentations to which I have contributed is available through my ResearchGate profile.
Professional and Technical Contributions
My professional activities extend beyond consulting and include contributions to statistical computing, the regulatory use of R (a statistical computing environment), and the clinical research community.
- Member of The American Statistical Association
- Member of The Society for Clinical Trials
- Member of 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
- Contributed foundational R code (R-IQ-OQ) now used in the rqualify package for IQ/OQ qualification of R in regulatory settings
- Editorial Board - The Journal of Statistical Software (Past)
If you are looking for senior-level independent biostatistical expertise for a post-approval or post-market study, or for an independent biostatistician to serve on a DSMB/DMC for a regulatory-submission study, I would welcome the opportunity to discuss your requirements.
Contact me to schedule an initial consultation.
Contact Me To Schedule An Initial Consultation:
Marc Schwartz
MS Biostatistics, LLC
Clermont, FL 34715
