Senior Manager of 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, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ( or follow us on LinkedIn ( . **Job Overview** We are currently seeking a dynamic, highly motivated, experienced individual for the position of **Senior Manager of Biostatistics** to serve as lead statistician for one or more clinical studies. He or she works closely with the clinical team on the statistical design of the studies, and the analysis and data presentations for the studies. **Job Duties and Responsibilities** + Serve as the lead statistician for one or more clinical studies, overseeing statistical design, authoring statistical sections of study protocols and Statistical Analysis Plans (SAPs), and supporting trial design, including sample size calculations and randomization schemes. + Lead the Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teamsincluding clinical development, clinical operations, data management, programming, and medical writingto maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to labeling claims. + Review Case Report Forms (CRFs) to ensure data collection aligns with protocol-defined analyses. + Develop data presentation plans and design Table, Listing, and Figure (TFL) shells. + Provide guidance to statistical programmers on SDTM/ADaM datasets and TLF specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts to ensure accuracy in data presentations and TFLs. + Drive the implementation of innovative statistical methods and trial designs. + Plan, manage, and oversee statistical activities conducted by Contract Research Organizations (CROs). **Key Core Competencies** + Solid knowledge of statistical methodologies for oncology, including survival analysis and Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations + Advanced proficiency in BASE SAS and R, or other statistical software is advantageous + Effective verbal and writing skills **Education and Experience** + Bachelor's degree in a related field required. + PhD or MS in statistics or biostatistics or related fields. + Minimum of 3 years (for PhD) and 5 years (for MS) related experience or equivalent combination of education and experience The base salary range for this role is $150,320 to $187,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. 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 ( or follow us on LinkedIn ( . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_