Associate Director, Biostatistics
About the role
Otsuka Pharmaceutical Company is seeking an Associate Director, Biostatistician to join our dynamic team. This is a strategic and critical leadership role for driving development of protocols and statistical designs in early phase clinical trials to support critical development decisions and advance drug candidates through clinical development.
Responsibilities
- Provide strategic statistical leadership for early development programs, including First-in-Human (FIH), Phase 1, Phase 1b/2a, and proof-of-concept studies.
- Lead statistical input into study design, protocol development, analysis planning, interpretation, and reporting of early-phase clinical trials.
- Develop innovative statistical strategies to address key development questions related to safety, dose selection, proof-of-concept, and go/no-go decisions.
- Serve as the lead statistician for one or more assets and represent Biostatistics on cross-functional asset teams.
- Partner closely with Clinical Development, Clinical Pharmacology, Clinical Management, Regulatory Affairs, Data Management, and Statistical Programming.
- Drive evidence-based decision-making through integration of safety, efficacy, PK/PD, biomarker, and translational data.
- Support key development milestones, including proof-of-concept evaluations, dose selection, and development planning.
- Influence program strategy by assessing development risks and recommending statistically sound approaches to maximize probability of success.
- Serve 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.
- Manage, mentor, and develop biostatisticians, fostering technical excellence.
Requirements
Knowledge/ Experience and Skills:
- Understand the company's products, the competition, and the pharmaceutical industry in general.
- Demonstrate a competent knowledge of the company's work tools, processes, and policies.
- Maintain a current awareness of new drug developments and statistical methodologies in the business.
- Demonstrated experience leading Phase 1 and early-phase clinical studies, including FIH, dose-escalation, dose-expansion, and proof-of-concept trials.
- Strong working knowledge of applicable U.S. regulatory requirements relevant to clinical trial design, analysis, and reporting.
- Prominent ability to partner effectively with Clinical Development, Clinical Pharmacology, Translational Medicine, Regulatory Affairs, and other key stakeholders.
- Experience working within matrixed, multidisciplinary drug development teams.
- Ability to influence decisions in a matrix environment without direct authority.
- Demonstrated ability to support and champion novel statistical approaches that improve decision-making when working with limited or variable early phase clinical data.
- Ability to communicate complex statistical concepts and insights clearly to technical and non-technical audiences.
- 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).
- 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
Qualifications
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.