The Director, Statistical Innovation is responsible for providing statistical leadership in evaluating, developing and deploying advanced and novel statistical/analytical methodology and associated tools in Clinical Development. This leader proactively drives Development forward by providing strategic methodological and operational solutions to Mallinckrodt's (MNK) most challenging clinical development problems. A strong individual contributor and a dynamic team leader, the Director of Statistical Innovation collaborates with statistical, clinical, and regulatory experts to broadly impact the portfolio by creating new ways to advance medicines to patients.. Principal Responsibilities. Deploy modeling and simulation capabilities and activities in support of drug development scenario planning and program optimization. Lead the discussion on modeling and simulation application and maximize the value of associated techniques. Provide consulting for statisticians and clinical teams.. Collaborate with different S&T Department/Divisions to optimize clinical trial study designs and programs. Inform clinical development evaluations via modeling and simulation and other methodology as appropriate. Operate as a full partner to clinical and scientific leadership. Ensure effective partnership with other functions including clinical, regulatory, operation functions to drive quantitative decision making in drug development and enable successful impact on development programs and trials.. Serve as a leading representative engaging on external industry challenges like Adaptive Designs, data mining applications, advanced analytics and complex innovative designs. Represent MNK externally on advanced and emerging topics.. Educate MNK statisticians and clinicians on emerging or existing advanced statistical methodology. Organize MNK statistical advisory boards with external experts. Explain complex methodological concepts to Senior S&T and R&D leaders. Drive change through influence, negotiation and collaboration. Create tools (e.g., R-shiny, SAS, R etc.) and platforms that operationalize key methodology making diverse approaches available to study teams. Department specific/Non-essential responsibilities :. Other duties as assigned with or without accommodation.. Minimum Requirements. Education Required:. PhD in statistics or related field. Experience / Skills:. 8+ years of experience in the pharmaceutical or biotechnology field. Strong oral and written communication skills. Demonstrated project and technical leadership qualities, and creative and strategic thinking required. Knowledge of FDA/CHMP guidelines, GCP, Clinical research, Fundamentals of Project Management, working in a matrix-based environment is a must.. Must be comfortable with hands on analysis of data using novel statistical techniques. Competencies:. Demonstrated expertise in advanced statistical methods (e.g. Adaptive designs, Bayesian methods, multiplicity, subgroup identification/data mining, predictive modeling etc.).. Functional knowledge of machine learning/AI and Big Data.. Experience in Modeling and Simulation in support of drug development programs. Ability to communicate with clarity and influence to drive change and innovation.. Organizational Relationship/Scope:. This position will work with multiple functions outside of Clinical Development. Key Stakeholders. At Mallinckrodt, we use strategic vision and employee-driven momentum to pursue a powerful mission:. Managing Complexity. Improving L... Associated topics: biostatistics, data analyst, probability, statistics, c
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