Associate Director, Biostatistics

Associate Director, Biostatistician

Otsuka Pharmaceutical Company, a global healthcare company, seeks an Associate Director, Biostatistician to provide statistical leadership for early development programs including FIH, Phase1, Phase1b/2a, and proof-of-concept studies.

Responsibilities

• Provide strategic statistical leadership for early development programs.
• Lead statistical input into study design, protocol development, analysis planning, interpretation, and reporting of early-phase clinical trials.
• Develop innovative statistical strategies to address key development questions related to safety, dose selection, proof‑of‑concept, and go/no‑go decisions.
• Serve as the lead statistician for one or more assets and represent Biostatistics on cross‑functional asset teams.
• Partner closely with Clinical Development, Clinical Pharmacology, Clinical Management, Regulatory Affairs, Data Management, and Statistical Programming.
• Drive evidence‑based decision‑making through integration of safety, efficacy, PK/PD, biomarker, and translational data.
• Support key development milestones, including proof‑of‑concept evaluations, dose selection, and development planning.
• Influence program strategy by assessing development risks and recommending statistically sound approaches to maximize probability of success.
• Serve as the Biometrics Trial Lead (BTL) and provide expertise and input regarding statistical analysis, TFLs format and data collection and quality, and overall timeline.
• Manage, mentor, and develop biostatisticians, fostering technical excellence.

Qualifications / Required Experience

• In‑depth knowledge of statistical principles, applications, and SAS/R programming software.
• Strong computer skills with demonstrated experience in Microsoft Word, Excel, PowerPoint, and Outlook.
• Demonstrated experience leading Phase1 and early‑phase clinical studies including FIH, dose escalation, dose expansion, and proof‑of‑concept trials.
• Strong working knowledge of applicable U.S. regulatory requirements for clinical trial design, analysis, and reporting.
• Proven ability to partner effectively with Clinical Development, Clinical Pharmacology, Translational Medicine, Regulatory Affairs, and other key stakeholders.
• Experience working within matrixed, multidisciplinary drug development teams.
• Ability to influence decisions in a matrix environment without direct authority.
• Demonstrated ability to support and champion novel statistical approaches that improve decision‑making when working with limited or variable early‑phase clinical data.
• Strong ability to communicate complex statistical concepts and insights clearly to technical and non‑technical audiences.
• Education: PhD or Master’s degree in Statistics or Biostatistics with Minimum 7 years (PhD) or 9 years (Master’s) of experience in the pharmaceutical industry.
• Experience in CNS area is a plus.
• Experience with early phase clinical trials, preferably first‑in‑human or PK/PD/biomarker‑focused studies is a plus.

Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.
• Company‑provided Basic Life, AD&D, Short‑term and Long‑term Disability insurance.
• Tuition reimbursement.
• 401(k) match.
• Paid holidays, paid leave programs, and other company‑provided benefits.

Competencies

• Accountability for Results.
• Strategic Thinking & Problem Solving.
• Patient & Customer Centricity.
• Impactful Communication.
• Influence at all levels.
• Respectful Collaboration.
• Empowered Development.

Compensation

Minimum $169,222.00 – Maximum $253,000.00, plus incentive opportunity. The range shown represents a typical pay range for individuals hired in the U.S.

Equal Opportunity Employer

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.

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.