Matthew Callahan

Matt Callahan, a seasoned Sr. Principal Clinical Data Scientist with over 15 years of experience, specializes in advancing pharmacovigilance, patient safety, and risk-based monitoring (RBM) through innovative clinical analytics and Data Science-as-a-Service (DSaaS) tools. At MaxisIT, he supports neurodegenerative disease, oncology, and immuno-oncology programs across Phase I-III trials, driving solutions that enhance data quality, streamline workflows, and empower data-driven decisions. With expertise in computational biology, biomedical science, biostatistics, and project management, Matt is dedicated to delivering impactful informatics solutions that optimize clinical operations.

Served as a technical lead for the design, development, and deployment of advanced Spotfire dashboards to support clinical trial data analysis, monitoring, and reporting for oncology and rare-disease biotech/CRO/pharma clients, via targeted FSP delivery-models.  Combined clinical domain expertise with strong data visualization and statistical and AI/ML-programming skills (in TIBCO Spotfire) to enable data-driven insights across cross-functional teams in drug-discovery (including: Clinical Development, Biometrics, and Clinical Operations…)

-Design and develop interactive Spotfire dashboards for real-time data monitoring of clinical trial datasets (e.g., CDISC (SDTM/ADaM), lab data, safety & PV data, ClinOps, RBQM, efficacy data, PK/PD, pre-clinical, CDM, biomarker discovery and translational medicine); using programming in R, SAS, SQL/proc-SQL, Python

-Translate complex clinical trial requirements into analytical visualizations that support decision-making for Data Review, Medical Monitoring, and Risk-Based Monitoring (RBM)
-Collaborate with Biostatisticians, Clinical Programmers, and Data Managers to integrate data from multiple sources (EDC, CTMS, IRT, Labs, Safety)

-Write and optimize custom expressions, calculated columns, and IronPython scripts to automate workflows and enhance dashboard interactivity

-Ensure visualizations comply with clinical data standards (e.g., CDISC) and support data quality checks, medical review, and regulatory submission deliverables

-Lead validation efforts for dashboard functionality and ensure consistency with statistical outputs and TLFs

-Contribute to the development of visualization libraries, templates, and best practices for reuse across clinical programs

Environment & Tech-Stack: 

MaxisIT - CTRenaissance®, Tableau, TIBCO Spotfire (v 7.11, 10.3 LTS, 11.4 LTS, 12.0 LTS, 14.0 LTS) – SQL/procSQL, Spotfire Analyst API (IronPython 2.7.11, C#, and Python Data Functions), TIBCO Spotfire® Enterprise Runtime for R (TSSS-TERR 6.0, 6.1), R 4.4.3, R-Studio/R-Shiny, SAS 9.4 Desktop

MPH - Biostatistics (UMass Medical School - Worcester, MA)