Senior Director, Biostatistics

Otsuka Pharmaceutical Companies (U.S.) · United States · 1 mo ago

RemoteRemoteAnalyst$231k/yrFull-time

About the role

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.

Responsibilities

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.
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.
Engages externally with health authorities, leading and participating in 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, acting as a point of escalation and resolution for biostatistical issues across relevant therapeutic areas.
Fosters a culture focused on goal achievement and personal accountability through clear expectations, ongoing performance monitoring, and course correction as needed.
Serves as a member of Biostatistics Leadership Team, balancing innovation and intellectual curiosity with discipline and operational rigor, championing 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 stay current with emerging research, methodologies, and evolving regulatory expectations.
Allocates resources to meet company and project needs without compromising scientific rigor or quality.
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.
Advanced proficiency in SAS and related statistical programming concepts, with sufficient technical depth to meaningfully review, challenge, and guide analytic work.
Advanced 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.

Qualifications

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.
Advanced proficiency in SAS and related statistical programming concepts, with sufficient technical depth to meaningfully review, challenge, and guide analytic work.
Advanced 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.

Skills

Statistical principles and applications, including modeling and simulation.
Statistical interpretation and regulatory compliance.
Effective communication and presentation skills.
Leadership and mentorship skills.
Collaboration and teamwork.

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.

Pay

$230,720.00 - $345,000.00, plus incentive opportunity.

Schedule

N/A

Application Deadline

This will be posted for a minimum of 5 business days.

Company 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, and paid leave programs as well as other company-provided benefits.

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.

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