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.
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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, regulatory use of R, 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
