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Otsuka Pharmaceutical Companies (U.S.) · 3 days ago
Director, Biostatistics
Princeton, NJ
Full-time
Hybrid
Director
10+ years exp
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Responsibilities
Oversee and be responsible for statistical work in late development phase for one or multiple compounds.
Collaborate with other functions such as clinical, clinical pharmacology, clinical operations, and regulatory.
Ensure scientific rigor when applying statistical methods in clinical trials.
Provide statistical expertise/input in the clinical development plan.
Provide technical guidance to statisticians and statistical programmers to ensure high quality and timely deliverables.
Support regulatory interactions and participate in regulatory meetings to address statistical questions.
Engage with the external statistical community and maintain awareness of new statistical methodology and regulatory guidance.
Qualification
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Required
PhD or M.S. in Statistics or Biostatistics
Minimum of 10 (or 12 for M.S.) years of experience in the pharmaceutical or related industry
Preferred
Strong knowledge of clinical trial (especially late-phase) development and regulatory guidance
Strong working knowledge of regulatory submissions for NDA and sNDA
Demonstrate ability to work in a team environment with the ability to mentor junior statisticians
Management experience
In-depth knowledge of statistical principles and applications in late-phase clinical trials
Excellent communication (oral and written), interpersonal, and leadership skills
Strong computer skills such as SAS, R, and other statistical software
Demonstrated experience working with Microsoft suite of programs
Experience in infectious diseases clinical trials and survival analysis
Company
Otsuka Pharmaceutical Companies (U.S.)
There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.
1,001-5,000 employees
Funding
Current Stage
Late StageLeadership Team
Kabir Nath
Senior Managing Director, Global Pharmaceutical Business
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