Director, Biostatistics

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director, Biostatistics  The Director of Biostatistics will provide strategic and statistical direction on clinical development plans, protocols and analysis, reviews clinical study reports and regulatory submission materials, and ensures that standard procedures are followed within projects. The Director will be responsible for implementing consistent statistical conduct for the responsible projects and liaising with global Data Science team and clinical research personnel in order to identify and meet their statistical support needs. Additionally, this position will play a role in supporting Real-World Data (RWD) and Real World Evidence (RWE) efforts, enabling the RWD team to generate supportive evidence for regulatory purposes, enhancing the value of our commercialized assets, and improving the success of our clinical programs. The Director will also represent Biostatistics in meetings with executive committees, commercial, regulatory agencies, and external development partners. This position reports to Head of Computational Research and Analytics.

Job Duties and Responsibilities

• Statistical Expertise: Serves as a Subject Matter Expert, providing statistical expertise to study designs and clinical development strategy to ensure scientific integrity.  
• RWD/RWE Integration: Collaborates with RWD team to generate RWE for regulatory submissions, support label updates, and enhance commercial and clinical program success. In addition, provides inputs to the RWD/RWE strategy. 
• Analysis Plans: Develops and reviews statistical analysis plans, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports. 
• Methodological Application: Utilizes methods for handling missing data, multiple comparisons and multiple endpoints, interim analyses, and simulation techniques. 
• Regulatory Support: Provides input to development programs, including filing strategies worldwide, study design, analytic methods, endpoints that meet both regulatory and scientific requirements. 
• Health Authority Engagement: Prepare statistical analysis plans, and contribute to statistical methodology discussions with Health Authorities.  
• Utilizes knowledge of methods for handling missing data, multiple comparisons and multiple endpoints, interim analyses, and simulation techniques. 
• Protocol Preparation: Presents and discusses statistical considerations as the representative of the Biostatistics function at Protocol Review Meetings. 
• Regulatory Document Preparation: Writes and reviews regulatory documents including statistical analysis plans for integrated summary of safety (ISS),integrated summary of efficacy (ISE),statistical summary reports, and regulatory briefing books.  
• Inter-department Collaboration: Collaborates closely with Clinical Data Management, Statistical Programming, Clinical Research, Global Drug Safety, Regulatory and Project Management. Ensures that study/project-related biostatistics and programming work is carried out in a timely and compliant manner. 
• Leadership and Innovation: Collaborates with cross-functional clinical development teams, researches and applies new statistical procedures and keeps abreast of advancements in relevant fields.   
• Communication and Presentation: Present and discus