Senior Director, Biostatistics

🕒 June 29

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Provides leadership, oversight, and technical/scientific direction across multiple therapeutic areas • Leads and develops a high-performing biostatistics team • Plans, directs, and oversees the design, preparation, and execution of biostatistical strategy • Ensures appropriate application of sound statistical theory and methodologies • Provides scientific review and oversight of key development materials • Engages externally with health authority interactions • Manages resource planning, prioritization, timeline management, and functional outsourcing • Acts as a point of escalation and resolution for biostatistical issues • Models and enables best practices for scientific engagement • Ensures adherence to regulatory standards and industry best practices

🎯 Requirements

• PhD in Statistics or Biostatistics • 12+ years of progressive experience in the pharmaceutical or biotechnology industry • Minimum of 5 years of demonstrated people leadership experience • Deep understanding of the clinical development process, from study design and development planning through regulatory submission • Strong working knowledge of global regulatory and industry best practices • Demonstrated experience supporting development programs across multiple therapeutic areas • Proven expertise in statistical methodologies supporting clinical study design and analysis • Advanced proficiency in SAS and related statistical programming concepts • Proficiency in standard business applications, including MS Office • Excellent communication, interpersonal, and leadership skills

🏖️ 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 • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company provided benefits