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Contact: Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com
No 3rd party candidates

We are seeking an experienced Biostatistics / Regulatory Strategy Consultant to provide strategic statistical and regulatory guidance related to clinical studies conducted in China. This individual will review existing and planned China-based clinical study designs and assess their suitability and potential considerations from a U.S. FDA regulatory perspective.

The ideal consultant is a senior biostatistician with significant regulatory strategy experience and a strong understanding of FDA expectations for clinical evidence generated outside the United States, particularly studies conducted in China. This role will serve as a strategic advisor, helping the team identify potential statistical or regulatory risks, gaps, and considerations associated with the study designs.

Responsibilities

• Review clinical study designs and statistical methodologies for studies conducted in China.
• Assess study designs from both a biostatistical and U.S. regulatory perspective, with particular focus on FDA review expectations.
• Provide strategic guidance regarding the potential acceptability and applicability of China-generated clinical data in support of U.S. regulatory objectives.
• Evaluate statistical considerations including study design, endpoints, analysis populations, sample size, methodology, and interpretation of results.
• Identify potential statistical, methodological, or regulatory gaps that could affect FDA review or acceptance of clinical evidence.
• Advise on differences or considerations between China-based clinical development approaches and U.S. FDA expectations.
• Recommend strategies to address identified gaps or risks and strengthen the overall evidence package.
• Partner with clinical, regulatory, and statistical stakeholders to provide clear, actionable recommendations.
• Participate in targeted discussions and strategic reviews on an as-needed, part-time basis.

Qualifications

• Advanced degree (PhD strongly preferred) in Biostatistics, Statistics, or a related quantitative discipline.
• Significant biostatistics experience within the pharmaceutical or biotechnology industry.
• Prior FDA experience or extensive direct experience supporting FDA interactions, submissions, and regulatory strategy.
• Demonstrated understanding of how the FDA evaluates clinical studies and clinical evidence generated in China and other ex-U.S. regions.
• Experience reviewing clinical study designs and statistical approaches from a regulatory perspective.
• Strong knowledge of FDA expectations related to clinical trial design, statistical methodology, and interpretation of clinical evidence.
• Experience providing strategic statistical guidance for regulatory submissions and/or interactions with regulatory authorities.
• Ability to identify potential regulatory and statistical risks and translate complex issues into practical recommendations.
• Experience working with China-based clinical development programs or evaluating China-generated clinical data for U.S. regulatory purposes strongly preferred.