Biostatistics / Regulatory Strategy Consultant Part-Time (Remote) Penfield Search Partners Fairfield, CT Job Details Contract 23 hours ago Qualifications FDA submissions Statistics Compliance risk assessment Doctoral degree in statistics Statistics Biostatistics-based research Risk mitigation strategy development Drug regulation Gap analysis Research project design Statistics research Ph.D. in statistics Doctor of Philosophy Pharmaceutical company experience Clinical program data analysis Communication with regulatory authorities for clinical trials Senior level Clinical data analysis Clinical research protocol design input

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Neisha Camacho/Terra Parsons - 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.