Sumitomo Pharma
Overview
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, and experienced individual for the position of
Manager of Biostatistics
to serve as trial 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. Responsibilities
Serve as the trial statistician for one or more clinical studies, supporting statistical design, authoring statistical sections of study protocols and SAPs, and supporting trial design, including sample size calculations and randomization schemes. Support 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 teams—including clinical development, clinical operations, data management, programming, and medical writing—to 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 is a plus. Advanced proficiency in BASE SAS and R, or other statistical software is advantageous. Effective verbal and writing skills. Education and Experience
PhD or MS in statistics or biostatistics related field required. PhD with 0-3 years or MS with 3 years related experience or equivalent combination of education and experience. Compensation and Benefits
The base salary range for this role is $127,520 to $159,400. Base salary is part of our total rewards package which also includes 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 time-off policy includes flexible paid time off, 11 paid holidays plus additional time off during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation will depend on candidate experience, skills, education and other factors permitted by law. Disclaimer:
The above statements describe the general nature and level of work and are not an exhaustive list of responsibilities. Confidential Data:
All information encountered is considered confidential. Compliance:
Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that plans and activities for SMPA and affiliates are carried out with high ethical standards. Mental/Physical Requirements:
Fast paced environment; must exercise judgment, have initiative and independence; excellent written and oral communication skills; ability to use a computer for extended periods. Equal Employment Opportunity:
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 status, sex, gender, sexual orientation, disability, veteran status, or other protected status.
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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, and experienced individual for the position of
Manager of Biostatistics
to serve as trial 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. Responsibilities
Serve as the trial statistician for one or more clinical studies, supporting statistical design, authoring statistical sections of study protocols and SAPs, and supporting trial design, including sample size calculations and randomization schemes. Support 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 teams—including clinical development, clinical operations, data management, programming, and medical writing—to 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 is a plus. Advanced proficiency in BASE SAS and R, or other statistical software is advantageous. Effective verbal and writing skills. Education and Experience
PhD or MS in statistics or biostatistics related field required. PhD with 0-3 years or MS with 3 years related experience or equivalent combination of education and experience. Compensation and Benefits
The base salary range for this role is $127,520 to $159,400. Base salary is part of our total rewards package which also includes 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 time-off policy includes flexible paid time off, 11 paid holidays plus additional time off during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation will depend on candidate experience, skills, education and other factors permitted by law. Disclaimer:
The above statements describe the general nature and level of work and are not an exhaustive list of responsibilities. Confidential Data:
All information encountered is considered confidential. Compliance:
Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that plans and activities for SMPA and affiliates are carried out with high ethical standards. Mental/Physical Requirements:
Fast paced environment; must exercise judgment, have initiative and independence; excellent written and oral communication skills; ability to use a computer for extended periods. Equal Employment Opportunity:
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 status, sex, gender, sexual orientation, disability, veteran status, or other protected status.
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