AssociateDirector,Biostatistics

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, 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_](https://www.us.sumitomo-pharma.com) or follow us on LinkedIn. This position reports to the Executive Director of Biostatistics and is an integral part of the oncology biostatistics team. The team supports all statistical deliverables within SMPA's oncology clinical development. The role involves leading statistical activities for oncology clinical projects and ensuring effective collaboration and alignment with cross-functional teams. **Essential Functions Required for Job** · **Lead Statistical Efforts** : Serve as the biostatistics lead for one or more studies within a project team, offering expertise in study design, operations, decision rules, and analysis planning. · **Develop and Oversee Statistical Documentation** : Author and oversee the production of statistical sections of protocols and analysis plans, and contribute to the statistical sections of publications across multiple clinical projects. · **Mentor and Manage Team Members** : Provide coaching and management for junior biostatisticians, fostering their professional development and ensuring high-quality output. · **Oversee CRO Statistical Activities** : Plan, manage, and supervise the statistical activities conducted by Contract Research Organizations (CROs) to ensure alignment with project objectives and standards. · **Provide Technical Guidance** : Offer guidance to junior statisticians and statistical programmers on developing SDTM/ADaM datasets and TLFs (Tab