Associate Director, Biostatistics

Location: Rockville, Maryland, or Princeton, New Jersey, United States; remote arrangements may also be considered under a hybrid work policy. Travel is expected 20% of the time.

Salary: $169,222–$253,000, plus incentive opportunity.

Company

Otsuka Pharmaceutical is a global healthcare company researching, developing, manufacturing, and marketing pharmaceutical and nutraceutical products.

What you will do

• Provide strategic statistical leadership for early development programs, including First-in-Human, Phase 1, Phase 1b/2a, and proof-of-concept studies.
• Lead study design, protocol development, analysis planning, interpretation, and reporting for early-phase clinical trials.
• Develop statistical strategies for safety assessment, dose selection, proof-of-concept evaluation, and go/no-go decisions.
• Act as lead statistician and Biometrics Trial Lead for assigned assets, contributing to statistical analysis, TFLs, data quality, and timelines.
• Partner with Clinical Development, Clinical Pharmacology, Translational Medicine, Regulatory Affairs, Data Management, and Statistical Programming.
• Manage, mentor, and develop biostatisticians while supporting evidence-based development decisions.

Requirements

• PhD or Master’s degree in Statistics or Biostatistics.
• Minimum 7 years of pharmaceutical industry experience with a PhD or 9 years with a Master’s degree.
• Demonstrated experience leading Phase 1 and early-phase clinical studies, including FIH, dose-escalation, dose-expansion, and proof-of-concept trials.
• Strong knowledge of U.S. regulatory requirements for clinical trial design, analysis, and reporting.
• In-depth knowledge of statistical principles and experience with SAS and R programming software.
• Ability to communicate complex statistical concepts, influence matrixed teams, and manage competing priorities.

Nice to have

• Experience in the CNS area.
• Experience with first-in-human or PK/PD- and biomarker-focused studies.

Culture & Benefits

• Medical, dental, vision, prescription drug, life, AD&D, and short- and long-term disability coverage.
• Tuition reimbursement and student loan assistance.
• 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Culture focused on accountability, strategic thinking, patient centricity, impactful communication, respectful collaboration, and professional development.