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 the 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 for approval of drug products in different phases of the 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:
- Write or review of statistical analysis plan and conducts/oversees statistical analyses.
- Effective communications with study team and key stakeholders across different functions such as clinical, CLIN pharm, operation, and clinical operation.
- Author statistics sections in summary documents and briefing book for regulatory interactions.
- Familiar with regulatory submission process in US and EU.
- Provide statistical analysis plan, including study design, sample size, primary and secondary endpoints, and statistical analysis method in protocol development.
- As core study/project team member, provide statistical input in different perspective of the clinical trial conduct such as CRF review, IRT setting, DMC set up, annual reports and PSUR.
- Develop 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.
- Discuss strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development.
- Review 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.
- Serve as the Biometrics project team leader in the project team and provides expertise and input regarding the statistical analysis, TFLs format and data collection and quality, and overall timeline.
- Provide technical supervision over other biostatisticians assigned to his/her therapeutic area and assigns them the statistical tasks.
- Responsible in managing biostatistical tasks for one therapeutic area and provides strategic technical support to other clinical projects.
- Provide technical direction to supporting statisticians working on projects on a day-to-day basis.
Minimum 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.
Preferred Knowledge, Skills, and Abilities:
- 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.
- In-depth knowledge of statistical principles, applications, and SAS/R programming software.
- Expertise in global commercialization, global regulations and protocols.
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.
- PTO 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.
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