Senior Director Biostatistics Head of Statistical Innovation & Methodology

Lead the identification, development, evaluation, and application of innovative statistical methodologies to support clinical development programs. Conduct and oversee methodological research on emerging statistical approaches, and guide the development of tools, algorithms, and analytical frameworks to enable their practical implementation in clinical development. Provide expert statistical consultation to clinical development teams, influencing program-level and portfolio-level decisions through rigorous quantitative evaluation and methodological insight. Shape statistical strategies for clinical trial design and analysis, including the development of quantitative decision frameworks, benefit-risk evaluations, and probability-of-success assessments. Serve as an internal subject-matter expert on advanced statistical methodologies, advising statisticians and cross-functional teams on complex design and analysis challenges. Engage externally with scientific organizations, regulatory agencies, and academic collaborators to contribute to methodological advancement, inform industry best practices, and ensure awareness of emerging statistical approaches. Mentor statisticians, promote knowledge sharing, and, as the function grows, build and lead a statistical innovation and methodology team to strengthen methodological expertise and foster a culture of statistical innovation within the Biostatistics organization. PhD in Statistics, Biostatistics, or a related quantitative discipline with 12+ years of experience in the pharmaceutical or biotechnology industry, including experience in statistical methodology or innovation roles. Strong expertise in clinical trial design, modern statistical methodologies, and simulation-based evaluation of trial operating characteristics. Proven track record of developing or applying advanced statistical methods to support drug development (e.g., adaptive designs, Bayesian methods, model-based decision frameworks). Experience providing methodological guidance to statisticians and cross-functional teams. Demonstrated ability to mentor statisticians, lead methodological initiatives, and communicate complex statistical concepts clearly to scientific and non-statistical stakeholders.

Biopharmaceutical company pioneering RNA interference (RNAi) therapeutics for rare genetic, cardiometabolic, and CNS diseases. Headquartered in Cambridge, MA.

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