Study Design and Statistical Insight for Clear, Confident Decisions

I work with life-science teams to design studies that turn scientific questions into reliable evidence. With more than a decade of experience in biostatistics, data management, and statistical programming across drugs, medical devices, and biologics, I provide clear guidance from study design through analysis and interpretation. My goal is simple: make statistics understandable, useful, and aligned with your scientific and regulatory needs.

Alyssa Wilmington, MS

What I do:

Study Design

Thoughtful, scientifically sound study design to set your project up for success - including protocol input, endpoint selection, and sample size justification.

Clinical Trial & Real‑World Evidence Analysis

Rigorous statistical analysis for clinical trials (Phase I–IV) and real‑world datasets, with clear interpretation and communication of results.

CRO Oversight

Independent oversight of CRO activities across statistics, data management, and statistical programming to ensure quality, consistency, and alignment with your goals.

Process Development & Audit Readiness

Creation or refinement of statistical and data‑related processes, documentation, and workflows to support compliance and prepare your team for audits or inspections.

Biometrics Team Building & Training

Support in building or expanding your biometrics function — from advising on hiring to training new team members in statistical concepts, data standards, and best practices.

What Sets Me Apart:

  • Proven biometrics leader delivering full end‑to‑end strategy and oversight of data management and statistical analyses across a global study portfolio

  • Over 10 years of hands‑on experience leading 50+ studies across multiple therapeutic areas, phases, and product types (drugs, devices, and biologics)

  • Direct access to the consultant doing the work

  • Clear, approachable communication that makes complex statistics easy to understand

  • Deep regulatory familiarity, supporting submissions and responses with leading authorities worldwide

  • Flexible engagement models, from one‑time analyses to ongoing fractional support

  • End‑to‑end expertise, from study design to data management to final reporting

How It Works:

  1. Initial Consultation

    We discuss your project, goals, timelines, and challenges

  2. Project Scoping

    I outline the approach, deliverables, and estimated effort

  3. Analysis and Collaboration

    I work closely with your team, providing updates and clear explanations throughout

  4. Delivery and Support

    You receive clean, well‑documented results, and I remain available for follow‑up questions or regulatory needs

Ready to Discuss?

Whether you need support with study design, statistical analysis, data management, or programming, I’m here to help you move forward with clarity and confidence.