VP, Biostatistics

Sumitomo Pharma America, Inc. (SMPA) is the U.S. subsidiary of Sumitomo Pharma Co., Ltd., a global pharmaceutical company focused on addressing patient needs in oncology, urology, women’s health, rare diseases, cell & gene therapies, and central nervous system (CNS) disorders. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, SMPA aims to accelerate discovery, research, and development to bring novel therapies to patients sooner.

About the role

This highly visible leadership and strategic position reports to the Chief Medical Officer – Oncology and is an integral part of the oncology leadership team. The role leads and develops the Biostatistics organization, including internal staff, external partners, and CROs, providing all statistical deliverables within SMPA’s oncology clinical development and medical affairs functions.

Responsibilities

• Serve as a strategic member of the Oncology Leadership Team, influencing portfolio strategy, development plans, regulatory strategy, and key investment decisions.
• Set the vision and leadership for the biostatistics function, providing the highest level of data and statistical advice across the function.
• Provide statistical leadership during regulatory interactions, including Health Authority meetings, NDA/BLA submissions, advisory committee preparation, and responses to regulatory questions.
• Lead necessary stakeholders to plan, direct, and coordinate a large and expanding dataset from a portfolio of oncology projects spanning Phase 1 through Phase 4 clinical development.
• Develop and roll out new initiatives to support scaling and growing the organization.
• Lead, inspire, guide, and mentor a team of statisticians.
• Influence cross-functional activities and provide strategic advice on the present and future direction of the statistics function.
• Provide senior management with statistical reviews of key documents (protocols, CSRs, regulatory briefings).
• Build a high-performing biostatistics organization culture through talent development, succession planning, operational excellence, and continuous process improvement.
• Drive innovation in statistical methodology, data science, and clinical development processes to improve decision-making and development efficiency.
• Communicate statistical issues on studies to clinical, regulatory, medical affairs, commercial teams, and senior leadership.
• Provide organizational leadership to manage the biostatistics budget.
• Oversee teams that author and oversee the production of statistical sections of protocols and analysis plans and contribute to the statistical sections of publications across multiple clinical projects.

Requirements

• PhD or MS in statistics or biostatistics (PhD preferred).
• Minimum 12+ years in clinical trials.
• At least 7 years of leadership experience at the VP level in drug development.
• Submitted oncology NDA/BLA within the past 7 years.
• Broad and thorough understanding of statistical principles, up-to-date statistical design and methodologies, and their applications in clinical trials.
• Strong statistical leadership in a multi-functional project environment: able to manage many projects simultaneously as well as conflicting priorities.
• Effective writing and communication skills: able to author various statistical documents and explain complex statistical design, methodology, decision rules, analysis plans, and statistical reports to teams.
• Working knowledge of SAS, R, and modern statistical computing environments sufficient to provide technical leadership and oversight.

Skills

• Leadership and Management: Demonstrated capability to lead and mentor teams, manage multiple programs and trials simultaneously, and drive and deliver quality results in a fast-paced environment.
• Communication Skills: Strong written and verbal communication skills with the ability to present complex statistical concepts to both technical and non-technical audiences.
• Collaboration: Proven ability to work effectively as part of a cross-functional team, fostering a positive and productive work environment, and be a preferred biostatistical partner to both statisticians and other functional team members.
• Problem-Solving: Strong analytical and problem-solving skills with the ability to make strategic decisions based on data-driven insights.
• Project Management: Ability to plan, organize, and manage biostatistical aspects of projects from start to finish.
• Statistical Expertise: In-depth knowledge of statistical methods and their application in oncology clinical trials, including experience with Bayesian modeling, complex trial designs, and analysis techniques.
• Regulatory Knowledge: Familiarity with regulatory guidelines and standards (e.g., FDA, EMA, ICH) relevant to biostatistics and clinical trials. Prior NDA/BLA and IND experience.
• Quality Control: Strong attention to detail and commitment to ensuring the accuracy and integrity of statistical analyses and programming outputs.

People Management

This position includes people-management responsibilities, including day-to-day supervision, workload planning, and ensuring team members have the resources and support needed to succeed.

Pay

The base salary range for this role is $296,700.00 – $370,900.00. Base salary is part of a total rewards package that 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, and 80 hours of paid sick time upon hire and each year thereafter.

Schedule

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