Stephanie Russell
Sr Director - Rtsm Solution Services @Medidata Solutions
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WORK HISTORY
Sr Director - Rtsm Solution Services @Medidata Solutions
US
Lead technical and operational advisory teams supporting trial design, data collection, and randomization strategies for global clinical programs.• Partner with product development teams to ensure technical capabilities align with evolving statistical and regulatory requirements.• Advise sponsors on trial-level statistical design, configuration, and regulatory-compliant implementation of Medidata Rave RTSM systems.• Conduct risk assessments, randomization/UAT oversight, and statistical review of technical deliverables to ensure protocol adherence and GCP compliance.• Collaborate with cross-functional stakeholders (clinical, data management, programming) to support integrated database specifications and trial readiness.• Deliver scientific presentations, training workshops, and lessons-learned sessions toimprove statistical best practices and operational efficiency.Key Achievements:• Served as statistical point of contact for multiple compounds, ensuring alignment of trial-level strategies with compound-level objectives.• Supported integrated analyses for submission packages and marketing authorizations.
EDUCATION
Southwest Jiaotong University
Bachelor, Bioinformatics
Penn State University
Master of Science - MS, Statistics
Penn State University
Graduate Certificate, Applied Statistics
ABOUT STEPHANIE RUSSELL
Clinical Development & Biostatistics Leader with 15+ years of experience in pharmaceutical research, clinical trial strategy, statistical analysis, and Randomization & Trial Supply Management (RTSM) solutioning for global Phase I–IV programs. Proven track record as a compound/indication lead, providing statistical and operational leadership from trial design through regulatory submission—while accelerating drug development through seamless Rave RTSM integrations. Recognized thought leader with presentations and panel discussions at SCOPE Summit and active network builder in the Global Clinical Supplies Group (GCSG) community.Expert in adaptive trial designs, modeling, simulation, CDISC-compliant data structures, and pragmatic approaches to personalized medicine challenges like cost and implementation.Core Competencies:• Clinical Trial Statistical Strategy & Design (Adaptive, Bayesian, Modeling & Simulation; RTSM Optimization)• Regulatory Submission & Health Authority Interaction (FDA, EMA, ICH-GCP)• CDISC Standards (SDTM, ADaM) & Integrated Database Specifications• Vendor Oversight, CRO Management & Quality Control• Data Analysis, Interpretation, and Scientific Communication (SCOPE Panels, GCSG Networking, Publications, Posters)• Leadership & Cross-Functional Collaboration Across Global Teams (US, Europe, Asia)• SAS, R, Java, Statistical Computing
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