Associate Director, Biostatistics

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 an Associate Director, Biostatistician, you will be a champion of Otsuka’s culture and values and will be responsible for providing statistical expertise/input in drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in the development of protocols and statistical designs in different phases of clinical trials leading to approval of drug products in different phases of clinical trials.

This position can be based in Princeton, New Jersey, or Rockville, Maryland. Remote arrangements can also be considered. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs. You will report to the Senior Director, Biostatistics.

Job Description

• Provides statistical analysis plan, including study design, sample size, primary and secondary endpoints, and statistical analysis method in protocol development for early or late phase clinical trials.
• As core study/project team member, provide statistical input in different perspectives 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, Translational Medicine, 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 the supporting statisticians working on projects on a day-to-day basis.

Qualifications/ Required
Knowledge/ Experience and Skills:

• 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 and ability to translate complex statistical concepts into actionable insights for non‑statistical audiences.
• Familiar with regulatory submission process in US and EU
• Experience mentoring, leading project teams, and managing statistical deliverables across multiple studies or phases.
• Demonstrates the ability to support and champion novel statistical approaches that improve decision‑making when working with limited or variable early phase clinical data.

Skills

• 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.

Educational Qualifications

• PhD or Master’s degree in Statistics or Biostatistics
• Minimum 7 years (PhD) or 9 years (Master’s degree) of experience in the pharmaceutical industry Experience in CNS area is a plus
• Experience with early phase clinical trials, preferably first‑in‑human or PK/PD/biomarker‑focused studies is a plus

Our Benefits:

• Comprehensive medical, dental, vision and prescription drug coverage
• Company provided Basic Life, AD&D, Short-term and Long-term Disability insurance
• Tuition reimbursement
• 401(k) match
• FTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits