Associate Director, Statistics, Medical & Real World Data Analytics

Job Summary

Otsuka is looking for a strong Clinical Statistician in the Medical and Real World Data Analytics organization to provide statistical expertise for analysis of clinical trials data beyond the study endpoints, including secondary, exploratory, subgroup analyses. The overall purpose is to support evidence generation towards design new trials, assessing economic value, supporting health technology assessments through statistical analyses of clinical and other data. The role will manage the timely execution of statistical and research methodological components to meet project objectives and has a thorough understanding of current requirements for statistical standards.

Otsuka is a dynamic organization where motivated individuals come together to create new products for better health. We're driven by our purpose : defying limitations to improve lives.

Job Description

Key Responsibilities :

• Work closely with internal data scientists and data programmers, and external stakeholders including Medical Affairs, Value and Real World Evidence to provide end-to-end statistical expertise and delivery of analyses.
• Actively participate in project / study team meetings. Develop statistical sections of protocols; participate in mock-ups, review, and approve tables, listings and graphs specifications.
• Closely work with Medical Affairs to support statistical design, conduct secondary analyses of clinical and other external data. Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions.
• Work closely with clinicians, programmers, other statisticians, data scientists, and publication managers to generate QC outputs for publications, review publications to ensure accuracy, quality and soundness of statistical methodologies; coordinate, oversee and ensure quality delivery from vendors and their resources.
• Design statistical analysis, conduct statistical analysis and interpretation of analyses results. Ensure quality and timelines are met.
• Participate in study concept, protocol and SAP development for Real World Studies and ensure appropriateness of study design, sample size and statistical methodologies proposed.
• Author analysis plans, including table, figure, listing shells, and review reports. Develop cross-functional data review plan, key reports, and data dissemination plan in order to facilitate the review, summary, and dissemination of key study data / results.
• Contribute to external interactions with regulators, payers, review boards, etc.

Qualifications

Required :

Preferred :