Role of the Project Statistician in an FDA Type C Meeting

Overall Positioning

In an FDA Type C Meeting, the Project Statistician serves as a key methodological lead, responsible for designing, justifying, and assessing the regulatory acceptability of proposed statistical approaches.

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Core Responsibilities

1. Lead Statistical Strategy

The Project Statistician:

• Proposes and compares alternative trial designs
• Explains why standard statistical approaches may be insufficient
• Justifies innovative or complex methods based on scientific rationale and feasibility

Typical topics include:

• Adaptive or Bayesian trial designs
• Estimand framework and intercurrent event handling
• Sample size determination and re-estimation
• Multiplicity control
• External controls / real-world data
• Platform or master protocols

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2. Primary Statistical Interface with FDA

During the meeting, the Project Statistician:

• Directly addresses questions from FDA statistical reviewers
• Provides clear methodological explanations without deferring to clinical or regulatory colleagues
• Clarifies assumptions, operating characteristics, and decision rules

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3. Regulatory Risk Assessment and Mitigation

The Project Statistician:

• Identifies potential statistical and design risks
• Discusses failure scenarios and their implications
• Proposes mitigation strategies aligned with regulatory expectations

This proactive risk framing is particularly important in Type C meetings.

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Role by Meeting Phase

Before the Meeting

The Project Statistician typically:

• Drafts key statistical questions for FDA feedback
• Contributes to or authors the statistical sections of the briefing package
• Anticipates FDA concerns and prepares responses
• Aligns internally with clinical and regulatory teams on acceptable options and boundaries

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During the Meeting

The Project Statistician:

• Presents statistical concepts when needed
• Responds to FDA follow-up questions in real time
• Focuses on clarification rather than debate
• Carefully notes FDA language and tone regarding acceptability

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After the Meeting

The Project Statistician:

• Interprets FDA feedback, including non-binding but directional comments
• Distinguishes between fundamental objections and conditional acceptance
• Translates feedback into actionable protocol and SAP updates
• Advises the team on feasibility, risk, and next steps

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Type C vs Type B: Statistical Role Comparison

Aspect	Type B Meeting	Type C Meeting
Primary focus	Regulatory milestones	Methodological exploration
FDA expectation	Finalized proposals	Clear rationale and logic
Statistical approach	Deterministic	Exploratory
Multiple design options	Typically no	Often yes
Risk tolerance	Low	Moderate

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Resume / Interview-Ready Statement

Served as statistical lead for FDA Type C meetings, driving methodological strategy, leading discussions with FDA statistical reviewers, and assessing regulatory risk for innovative trial designs.

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One-Sentence Summary

In an FDA Type C Meeting, the Project Statistician is the methodological authority who shapes FDA understanding and acceptance of the proposed statistical approach.