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Job Title: Director Biostatistics
Location: Princeton, NJ United States
Position Type: Full Time
Post Date: 09/22/2021
Expire Date: 11/22/2021
Job Categories: Biotechnology and Pharmaceutical
Job Description
Director Biostatistics

The Director of biostatistics will oversee statistical work in early and late development phases for multiple compounds. He/she will be a key member of core project teams. In collaboration with cross functional team members, He/she will be responsible from Biostatistics for development of the compound(s), including but no

t limited to efficient and effective trial design, analysis planning, modeling and simulation, submission reporting, advisory committee preparation and participation.

This role takes responsibility for ensuring scientific rigor when applying statistical methods in clinical trials and will supervise biostatisticians and mentor their career development.

Responsibilities include:

Oversight of statistical work in early and/or late development phase for multiple compounds.

Collaborates with other functions, such as clinical, clinical pharmacology, clinical operations and regulatory

Responsible for ensuring scientific rigor when applying statistical methods in clinical trials.

Provides statistical expertise/input in the clinical development plan

Provides technical guidance and support to statisticians to ensure high quality and timely deliverables

Provides statistical support for development of protocols, SA
CSR, summary documents, and briefing book for various regulatory interactions

Supports regulatory interactions and participates in regulatory meetings and addresses statistical questions

Participates in company-wide or functional initiatives, such as related to process improvements

Demonstrates ability to work with senior leaders and maintains close communication with stakeholders both within and outside of the function

Engages with external statistical community and has awareness of new statistical methodology and/or regulatory guidance


PhD or M.S. in Statistics or Biostatistics.

Minimum 10 (or 12 for M.S.) years of experience in the pharmaceutical or related industry. Experience in early phase development preferred.

Management experience preferred


Strong knowledge of clinical trial development
regulatory guidance

Strong working knowledge of regulatory submissions for NDA and sNDA

Demonstrate ability to work in a team environment

Demonstrate ability to supervise junior statisticians

In-depth knowledge of statistical principles and applications.

Strong computer skills such as SAS, R and other statistical software. Demonstrated experience in working with Microsoft suite of programs (Word, Excel, PowerPoint and Outlook)

Excellent communication, interpersonal, and leadership skills

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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 chan
ge res
ponsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Statement Regarding Job Recruiting Fraud Scams

Job postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.
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