Director, Biostatistics

Otsuka Pharmaceutical Co., Ltd. • Rockville, MD

63d • Hybrid

About The Position

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. As a Director of Biostatistics, you will be a champion of Otsuka’s culture and values and be a key member of core project teams and will be responsible for statistical work in late development phases for one or multiple compounds. In collaboration with cross functional team members, you will be responsible for Biostatistics for development of compound(s), including efficient and effective trial design, analysis planning, modeling and simulation, submission reporting, advisory committee preparation and participation. You will ensure scientific rigor when applying statistical methods in clinical trials and will mentor junior biostatisticians for their career development. You will report to the Executive Director of Biostatistics. This position can be based in Princeton, New Jersey, or Rockville, Maryland. Remote arrangements can also be considered for East Coast candidates. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs. Job Description: 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.

Requirements

• 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.
• 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.
• 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.

Nice To Haves

• People mManagement experience is a plus.
• Experience in rare diseases clinical trials a plus.

Responsibilities

• 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.

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 as well as other company provided benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 1,001-5,000 employees