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Otsuka Pharmaceutical Companies (U.S.) · 2 days ago

Director, Biostatistics

Rockville, MD

Full-time

Hybrid

Director/Executive

$183K/yr - $274K/yr

10+ years exp

Otsuka Pharmaceutical Company is a global healthcare company focused on innovative pharmaceutical and nutraceutical products. The Director of Biostatistics will oversee statistical work in late development phases for compounds, ensuring scientific rigor in clinical trials and mentoring junior biostatisticians.

Health CareMedical

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

The Director level biostatistician oversees and is responsible for statistical work in late development phase for one or multiple compounds in rare disease

Collaborate with other functions, such as clinical, clinical pharmacology, clinical operations, regulatory, data management and statistical programming

Take responsibility for ensuring scientific rigor when applying statistical methods in clinical trials

Provide statistical expertise/input/strategy in the clinical development plan

Provide technical guidance to statisticians and statistical programmers to ensure high quality and timely deliverables

Provide statistical oversight and support for development of protocols, SAP, CSR, summary documents, and briefing book for different regulatory interactions

Support regulatory interactions and participates in regulatory meetings and address statistical questions

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

Work with senior leaders and maintain close communication with stakeholders both within and outside of the function

Engage with external statistical community and maintain awareness of new statistical methodology and regulatory guidance

Qualification

PhDM.S. in StatisticsClinical trial developmentRegulatory submissions expertiseStatistical principles knowledgeSASRLeadership skillsMentoring junior statisticiansExperience in rare diseasesCommunication skillsTeam collaboration

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/BLA and sNDA/sBLA

Demonstrate ability to work in a team environment with the ability to mentor junior statisticians

Strong leadership skills. People management experience is a plus

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 rare diseases clinical trials 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.)

Glassdoor4.1

There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.

Founded in 1989

Rockville, Maryland, USA

1001-5000 employees

https://www.otsuka-us.com

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

Represents job field similar to this job

Trends of Total Sponsorships

2025 (8)

2024 (6)

2023 (11)

2022 (5)

2021 (9)

2020 (13)