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 ) .

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director, Biostatistics The Director of Biostatistics will provide strategic and statistical direction on clinical development plans, protocols and analysis, reviews clinical study reports and regulatory submission materials, and ensures that standard procedures are followed within projects. The Director will be responsible for implementing consistent statistical conduct for the responsible projects and liaising with global Data Science team and clinical research personnel in order to identify and meet their statistical support needs. Additionally, this position will play a role in supporting Real-World Data (RWD) and Real World Evidence (RWE) efforts, enabling the RWD team to generate supportive evidence for regulatory purposes, enhancing the value of our commercialized assets, and improving the success of our clinical programs. The Director will also represent Biostatistics in meetings with executive committees, commercial, regulatory agencies, and external development partners. This position reports to Head of Computational Research and Analytics.

Job Duties and Responsibilities

• Statistical Expertise: Serves as a Subject Matter Expert, providing statistical expertise to study designs and clinical development strategy to ensure scientific integrity.
• RWD/RWE Integration: Collaborates with RWD team to generate RWE for regulatory submissions, support label updates, and enhance commercial and clinical program success. In addition, provides inputs to the RWD/RWE strategy.
• Analysis Plans: Develops and reviews statistical analysis plans, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports.
• Methodological Application: Utilizes methods for handling missing data, multiple comparisons and multiple endpoints, interim analyses, and simulation techniques.
• Regulatory Support: Provides input to development programs, including filing strategies worldwide, study design, analytic methods, endpoints that meet both regulatory and scientific requirements.
• Health Authority Engagement: Prepare statistical analysis plans, and contribute to statistical methodology discussions with Health Authorities.
• Utilizes knowledge of methods for handling missing data, multiple comparisons and multiple endpoints, interim analyses, and simulation techniques.
• Protocol Preparation: Presents and discusses statistical considerations as the representative of the Biostatistics function at Protocol Review Meetings.
• Regulatory Document Preparation: Writes and reviews regulatory documents including statistical analysis plans for integrated summary of safety (ISS),integrated summary of efficacy (ISE),statistical summary reports, and regulatory briefing books.
• Inter-department Collaboration: Collaborates closely with Clinical Data Management, Statistical Programming, Clinical Research, Global Drug Safety, Regulatory and Project Management. Ensures that study/project-related biostatistics and programming work is carried out in a timely and compliant manner.
• Leadership and Innovation: Collaborates with cross-functional clinical development teams, researches and applies new statistical procedures and keeps abreast of advancements in relevant fields.
• Communication and Presentation: Present and discuss statistical considerations, analysis methodology, findings in various internal and external forums.

Key Core Competencies

• PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
• Solid knowledge of statistical methodology, clinical experimental design and analysis for clinical trials. CNS, urology, women's health or oncology therapeutic area expertise is a plus.
• Requires proficiency in SAS and R and an understanding of clinical data processing.
• Knowledge of CDISC requirements for SDTM and ADaM.
• Knowledge of FDA and ICH regulations/requirements as they pertain to the analysis, presentation/reporting, and monitoring of data.
• Knowledge and experience of generating RWE for regulatory purpose is plus.
• Understands roles of Biostatistics, Statistical Programming and Data Management and provides adequate statistical expertise within a cross-functional team in clinical development.
• Knowledge of other statistical and computational software packages (R, EaST, nQuery) is required.
• Experience contributing to content of INDs/NDAs/BLAs with eCTD formatted NDA/BLA submissions.

Communication & Interpersonal Skills

• Excellent verbal and written communication skills.
• Ability to effectively collaborate in a dynamic environment.

Significant Contacts :

• Interacts internally with global Data Science team (Biostatistics, Programming, Data Management), Real World Data Science within Computational Research and Analytics, Clinical Development/Operations and Regulatory concerning projects, operational decisions, or commitments impacting Biometrics and/or other functional areas.
• External interactions involve CROs and SMPA's corporate partners.

Education and Experience

Education

• Ph.D. and 8+ years of experience in Biostatistics; M.S. and 10+ years of experience in Biostatistics with extensive experience within the Pharmaceutical and/or Biotechnology industries

Experience

• Experience with analysis and reporting of phase 3 study data, as well as integrated summary of efficacy and safety (ISE and ISS).
• Experience with group-sequential designs and/or support of independent data monitoring committee for registration trials.
• Experience with statistical methodology and analysis for clinical trials and RWD studies in CNS, Urology, Ophthalmology, endocrinology or oncology.
• Experience contributing to content of INDs/NDAs/BLAs with eCTD formatted NDA/BLA submissions desired.
• Works in a changing and busy environment. Exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.
• Works independently, self-directed, high energy and strong work ethic. High degree of creativity, problem solving, latitude and attention to detail required
• Ability to work in a small, fast-paced environment covering a range of activities from document creation to agency interactions as the need arises
• Demonstrated strong leadership, project management, teamwork, and interpersonal skills
• Demonstrated ability to provide insight into patterns within data which sheds new light on optimal ways in which treatments should be used.

The base salary range for this role is $189,400 to $236,700. 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 unlimited 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) and Affirmative Action employer

Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All 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, gender identity or expression; 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.

For more information about EEO and the Law, please visit the following pages:

Equal Employment Opportunity is THE LAW )

EEO is the Law Poster Supplement

Pay Transparency )

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