Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Biostatistics. This role will support clinical development programs by providing strategic and technical leadership in the design, analysis, and reporting of clinical studies. The Senior Manager will collaborate with cross-functional teams to ensure statistical integrity, regulatory compliance, and innovative data-driven decision-making throughout the drug development lifecycle. This role will be working as a biostats liaison between Sumitomo Pharma (SMP) and Sumitomo Pharma America, Inc. (SMPA) teams for certain projects.

Job Duties and Responsibilities

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Statistical Leadership

Lead statistical activities for assigned clinical studies, including protocol development, statistical analysis plan (SAP) creation, and final study reporting.

Collaborate with cross-functional teams, including clinical, regulatory, and medical affairs, to ensure study designs meet scientific and regulatory standards.

Provide statistical expertise in study design, endpoint selection, sample size determination, and innovative methodologies (e.g., adaptive designs, Bayesian methods).

Analysis and Interpretation

Oversee and validate programming and statistical analyses conducted by internal or external teams.

Interpret and communicate statistical findings to non-statistical audiences, including senior leadership, regulatory agencies, and external stakeholders.

Prepare and present study results for regulatory submissions, publications, and internal decision-making.

Global Collaboration

Work closely with SMPA teams and collaborate with counterparts at Sumitomo Pharma (SMP) in Japan on global projects, ensuring alignment on statistical methodologies, regulatory strategies, and data analyses.

Participate in joint meetings and initiatives to harmonize processes and share best practices across regions.

Regulatory and Compliance

Ensure statistical deliverables comply with regulatory guidelines (FDA, EMA, ICH, etc.) and company SOPs.

Contribute to the preparation of regulatory submissions, including briefing documents, responses to agency queries, and integrated summaries of safety and efficacy (ISS/ISE).

Team Collaboration and Development

Mentor and guide junior biostatisticians and statistical programmers.

Work closely with data management, clinical operations, clinical research, and external vendors to align statistical requirements with operational deliverables.

Stay current on advancements in biostatistics, regulatory requirements, and industry trends to bring innovative solutions to SMPA.

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Key Core Competencies

Technical Skills

Proficiency in statistical programming languages such as SAS and R.

Strong understanding of statistical methodologies and clinical trial design.

Knowledge of CDISC standards (SDTM, ADaM) and data visualization tools.

Soft Skills

Excellent verbal and written communication skills.

Strong problem-solving and critical-thinking abilities.

Effective leadership and collaboration skills in a cross-functional team environment.

Education and Experience

Master’s degree in Statistics, Biostatistics, or a related field (Ph.D. preferred).

4+ years of biostatistics experience in the pharmaceutical, biotechnology, or CRO industry.

Proven track record of leading statistical activities for clinical trials in various phases (I-IV).

Experience with regulatory submissions (e.g., INDs, NDAs, BLAs) and interacting with health authorities.

Familiarity with therapeutic areas such as oncology, CNS, urology, or women’s health is a plus.

The base salary range for this role is $138,400 to $173,000. 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 (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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 https://www.us.sumitomo-pharma.com (https://c212.net/c/link/?t=0l=eno=4190475-1h=3440496098u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2Fa=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0l=eno=4190475-1h=2504638834u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2Fa=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