Associate Director, 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 or follow us on LinkedIn.

Job Overview:

The Associate Director, Biostatistics reports to the Vice President, Biostatistics and serves as the statistical lead for one or more clinical development programs. This position provides strategic statistical leadership across clinical development, including development planning, study design, quantitative decision-making, data analysis, regulatory submissions, and external collaborations. The Associate Director partners with cross-functional leaders to ensure that statistical strategies and deliverables are scientifically rigorous, operationally feasible, and aligned with program and regulatory objectives.

Essential Functions Required for Job

• Serve as the biostatistics lead for one or more clinical development programs, providing strategic statistical input into clinical development plans, study designs, operational decisions, decision criteria, and analysis strategies.
• Represent Biostatistics on cross-functional program and study teams and ensure that statistical considerations are incorporated into key development decisions.
• Lead statistical interactions with regulatory authorities, including the planning and preparation of briefing documents, responses to regulatory questions, and discussions of statistical methodology.
• Author or oversee the development and review of statistical sections of protocols, statistical analysis plans, regulatory submissions, publications, and other scientific documents.
• Provide statistical interpretation of study results, communicate benefit-risk considerations, and support data-driven program decisions.
• Identify statistical, operational, and regulatory risks and recommend practical mitigation strategies.
• Oversee CRO and external vendor statistical activities, including scope definition, quality review, timelines, and delivery of statistical outputs.
• Provide technical leadership, coaching, and mentorship to statisticians and statistical programmers, as appropriate.
• Evaluate and apply innovative statistical methods, including Bayesian approaches, adaptive or complex trial designs, and quantitative decision-making methods when appropriate.
• Contribute to departmental standards, process improvements, statistical governance, and capability development.

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Knowledge, Skills and Abilities :

• Broad and current knowledge of statistical principles, clinical-trial methodology, and their application throughout drug development.
• Strong understanding of applicable regulatory guidance, including ICH guidelines and expectations of FDA, EMA, PMDA, and other health authorities.
• Knowledge of relevant industry standards, including CDISC standards.
• Experience with complex trial designs, Bayesian methods, or innovative statistical approaches is preferred.
• Proficiency in statistical computing using SAS and R.
• Ability to communicate complex statistical concepts and recommendations clearly to technical and non-technical audiences.
• Demonstrated ability to provide strategic leadership, influence cross-functional decisions, and manage multiple priorities in a fast-paced environment.
• Proven ability to collaborate effectively across functions and communicate recommendations to senior leadership.

Education & Experience Requirements:

• PhD in Statistics, Biostatistics, or a related quantitative discipline with at least 5 years of relevant experience, or an MS with at least 8 years of relevant experience, in the pharmaceutical or biotechnology industry.
• Significant experience providing statistical leadership for clinical development programs and clinical trials.
• Experience supporting regulatory interactions and marketing applications is strongly preferred.
• Oncology or hematology clinical development experience is preferred.
• Experience overseeing CROs, vendors, or external statistical partners is required.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. 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.

The base salary range for this role is

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, in accordance with applicable law.

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.

Drug Screening Requirements
Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.

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 America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at [email protected]. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.