Senior Director, Biostatistics

Otsuka Pharmaceutical Co., Ltd.

8d • $230,720 - $345,000 • Onsite

About The Position

The Senior Director, Biostatistics, provides leadership, oversight, and technical/scientific direction across multiple therapeutic areas. This role leads and develops a high‑performing biostatistics team that delivers both strong scientific engagement and operational excellence throughout the clinical development lifecycle. Core responsibilities include trial design and development planning, statistical analysis strategy, modeling and simulation, regulatory submission support, advisory committee preparation, and scientific presentations. The Senior Director, Biostatistics plans, directs, and oversees the design, preparation, and execution of the biostatistical strategy supporting research and development, ensuring the appropriate application of sound statistical theory and methodologies across designated therapeutic areas. In support of Clinical Development strategy, this role provides scientific review and oversight of key development materials, including but not limited to clinical protocols, statistical analysis plans, health authority submission documents, and publication materials. External scientific engagement is a core accountability of the role, including leadership of and participation in health authority interactions. Operational excellence is demonstrated through the effective and efficient delivery of the Clinical Development portfolio, including resource planning, prioritization, timeline management, and functional outsourcing. The Senior Director serves as a senior statistical subject‑matter expert and knowledge resource to cross‑functional project teams and acts as a point of escalation and resolution for biostatistical issues across relevant therapeutic areas. This role models and enables best practices for scientific engagement, fostering strong thought partnerships and a collaborative environment that encourages rigorous discussion and constructive debate. The individual cultivates a culture focused on goal achievement and personal accountability through clear expectations, ongoing performance monitoring, and course correction as needed. As a member of Biostatistics Leadership Team, the Senior Director balances innovation and intellectual curiosity with discipline and operational rigor. The role champions value‑added change, continuous improvement, and evolution of statistical practices, while inspiring and motivating others. The Senior Director ensures adherence to regulatory standards and industry best practices for statistical design, analysis, and reporting. The role also establishes and maintains external scientific relationships to remain current with emerging research, methodologies, and evolving regulatory expectations. This position is responsible for allocating resources to meet company and project needs without compromising scientific rigor or quality. The Senior Director directly supervises and develops biostatistics staff, including mentoring, training, performance management, and hiring.

Requirements

• PhD in Statistics or Biostatistics with 12+ years of progressive experience in the pharmaceutical or biotechnology industry, including extensive involvement in clinical research and late-stage development programs
• Minimum of 5 years of demonstrated people leadership experience, including responsibility for hiring, developing, mentoring, and performance management of biostatistics professionals
• Deep and end-to-end understanding of the clinical development process, from study design and development planning through regulatory submission (e.g., NDA/BLA) and post-submission activities
• Strong working knowledge of global regulatory and industry best practices, including protocol and SAP development, statistical interpretation, and health authority expectations
• Demonstrated experience supporting development programs across multiple therapeutic areas, with the ability to rapidly develop subject-matter understanding in new disease areas
• Proven expertise in state-of-the-art statistical methodologies supporting clinical study design and analysis, including application of innovative or complex methods where appropriate
• Strong foundation in statistical principles and applications, including modeling and simulation, and the ability to provide strategic technical guidance beyond routine analyses
• Advanced proficiency in SAS and related statistical programming concepts, with sufficient technical depth to meaningfully review, challenge, and guide analytic work
• Proficiency in standard business applications, including MS Office (Word, Excel, PowerPoint, Outlook), with the ability to communicate complex statistical concepts clearly to diverse audiences
• Demonstrated ability to apply organizational policies and procedures effectively across complex and ambiguous situations, exercising sound judgment and leadership
• Excellent communication, interpersonal, and leadership skills, with a proven ability to influence cross-functional stakeholders, foster collaboration, and represent Biostatistics effectively at senior levels

Responsibilities

• Provides leadership, oversight, and technical/scientific direction across multiple therapeutic areas.
• Leads and develops a high-performing biostatistics team.
• Delivers strong scientific engagement and operational excellence throughout the clinical development lifecycle.
• Plans, directs, and oversees the design, preparation, and execution of the biostatistical strategy supporting research and development.
• Ensures the appropriate application of sound statistical theory and methodologies across designated therapeutic areas.
• Provides scientific review and oversight of key development materials, including clinical protocols, statistical analysis plans, health authority submission documents, and publication materials.
• Leads and participates in health authority interactions.
• Demonstrates operational excellence through effective and efficient delivery of the Clinical Development portfolio, including resource planning, prioritization, timeline management, and functional outsourcing.
• Serves as a senior statistical subject-matter expert and knowledge resource to cross-functional project teams.
• Acts as a point of escalation and resolution for biostatistical issues across relevant therapeutic areas.
• Models and enables best practices for scientific engagement, fostering strong thought partnerships and a collaborative environment.
• Cultivates a culture focused on goal achievement and personal accountability.
• Champions value-added change, continuous improvement, and evolution of statistical practices.
• Ensures adherence to regulatory standards and industry best practices for statistical design, analysis, and reporting.
• Establishes and maintains external scientific relationships to remain current with emerging research, methodologies, and evolving regulatory expectations.
• Allocates resources to meet company and project needs without compromising scientific rigor or quality.
• Directly supervises and develops biostatistics staff, including mentoring, training, performance management, and hiring.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage
• Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance
• Tuition reimbursement
• Student loan assistance
• A generous 401(k) match
• Flexible time off
• Paid holidays
• Paid leave programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree