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 https://www.us.sumitomo-pharma.com 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 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
• 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 gener