About this role
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 or follow us on LinkedIn.
Position Summary The Senior Manager, Biostatistician provides statistical leadership and support for oncology clinical development programs from protocol development through clinical study reporting and regulatory submission. The individual serves as the lead statistician for one or more clinical studies and collaborates with cross-functional teams including Clinical Development, Statistical Programming, Data Management, Clinical Operations, Medical Writing, Regulatory Affairs, and external partners to ensure the successful execution of clinical trials. Essential Functions Required for Job Serve as lead statistician for one or more oncology clinical studies.
Provide statistical input into study design, endpoint selection, sample size determination, randomization methodology, and analysis strategy. Contribute to the development and review of clinical study protocols. Author and review Statistical Analysis Plans (SAPs).
Collaborate with Statistical Programming in the development and review of analysis datasets, tables, listings, and figures (TLFs). Review statistical outputs and ensure the quality, consistency, and accuracy of study deliverables. Interpret study results and communicate findings to multidisciplinary project teams.
Contribute to the preparation of Clinical Study Reports (CSRs), abstracts, publications, and regulatory documents. Support regulatory submissions and responses to health authorities. Collaborate with CRO statisticians and programming teams to ensure timely and high-quality deliverables.
Ensure compliance with regulatory requirements, company procedures, and industry standards. Participate in departmental initiatives to improve statistical processes and standards. Provide technical guidance and mentoring to junior statisticians as needed.
Knowledge, Skills and Abilities Scientific rigor and strong attention to detail. Effective written and verbal communication skills. Ability to communicate statistical concepts to both technical and non-technical audiences.
Strong organizational and project management skills. Ability to manage multiple priorities in a fast-paced development environment. Commitment to quality, innovation, and continuous improvement.
Professional Experience / Qualifications MS or PhD in Statistics, Biostatistics, or a related quantitative discipline. Minimum 1 year of relevant industry experience with a PhD, or 3 years of relevant industry experience with an MS degree. Strong understanding of statistical principles and clinical trial methodology.
Working knowledge of FDA, EMA, PMDA, ICH, and other applicable regulatory guidelines. Familiarity with CDISC standards, including SDTM and ADaM. Experience supporting the design, analysis, and reporting of clinical trials.
Proficiency in SAS programming; experience with R is desirable. Strong analytical, problem-solving, and communication skills. Ability to work effectively in a cross-functional team environment.
Experience contributing to protocols, SAPs, CSRs, and regulatory submission documents. Oncology clinical development experience is preferred. Experience working with CROs and external vendors is desirable.
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. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment.
An employer who violates this law shall be subject to criminal penalties and civil liability. 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.