Otsuka Pharmaceutical Companies (U.S.) · 3 hours ago
Associate Director, Biostatistics
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$165K/yr - $246K/yr
7+ years expOtsuka Pharmaceutical Company is a global healthcare company focused on innovative pharmaceutical and nutraceutical products. The Associate Director, Biostatistics will provide statistical expertise in drug development, including clinical trial protocols and regulatory submissions, while managing biostatistical tasks and leading project teams.
Health CareMedical
Responsibilities
Provides statistical analysis plan, including study design, sample size, primary and secondary endpoints, and statistical analysis method in protocol development
As core study/project team member, provide statistical input in different perspective of the clinical trial conduct such as CRF review, IRT setting, DMC set up, annual reports and PSUR
Develops Statistical Analysis Plan (SAP) and mock TFLs for interim or final analyses
Participate strategic planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages
Support statistical needs for market access and publications
Core team of developing final study report (FSR), including authoring statistical sections
Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development
Reviews clinical, statistical, and regulatory literature for current clinical trial results, regulatory trends and new statistical methods to be applied on his/her assigned therapeutic area
Attend FDA meetings, FDA advisory boards, or other scientific meetings
Serves as the Biometrics Trial Lead (BTL) in the project team and provides expertise and input regarding the statistical analysis, TFLs format and data collection and quality, and overall timeline
Provides technical supervision over other biostatisticians assigned to his/her therapeutic area and assigns them the statistical tasks
Takes full responsibility in managing biostatistical tasks (as listed above) for one therapeutic area and provides strategic technical support to other clinical projects
Provides technical direction to supporting statisticians working on projects on a day-to-day basis
Qualification
Required
PhD or Master's degree in Statistics or Biostatistics
Minimum 7 years (PhD) or 9 years (master degree) of experience in the pharmaceutical industry
Understands the company's products, the competition, and the pharmaceutical industry in general
Demonstrates a competent knowledge of the company's work tools, processes, and policies
Maintains a current awareness of new drug developments and statistical methodologies in the business
Requires a strong working knowledge of applicable U.S. regulatory requirements and NDA preparation for submissions
Effective communications within biostatistics function and with study team and key stakeholders across different functional areas such as clinical, regulatory affairs, asset management, safety and clinical operation
Familiar with regulatory submission process in US and EU
In-depth knowledge of statistical principles, applications, and SAS/R programming software
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
Knows how/when to apply organizational policy or procedures to a variety of situations
Preferred
Experience in CNS area is a plus
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
Other company provided benefits
Company
Otsuka Pharmaceutical Companies (U.S.)
There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.
1001-5000 employees
H1B Sponsorship
Otsuka Pharmaceutical Companies (U.S.) has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (8)
2024 (6)
2023 (11)
2022 (5)
2021 (9)
2020 (13)
Funding
Current Stage
Late StageLeadership Team
Tarek Rabah
President & CEO
Reza Moghadam
Co-founder and lead for PsychU (www.PsychU.org)
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