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

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline: This will be posted for a minimum of 5 business days.

Company 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, and paid leave programs as well as other company provided benefits.

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 change responsibilities to meet business and organizational needs as necessary.