Description

The senior biostatistician plays a crucial role in the development and implementation of clinical trials, contributing to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. Additionally, they assist in administrative work related to Biostatistics Japan.

The senior biostatistician is responsible for:

• Authoring and reviewing various study-level specification documents, including protocol synopsis, statistical analysis plan, data presentation plan, case-report forms, and clinical study reports.
• Driving the design of innovative and efficient clinical trials, developing trial designs that address study objectives to support regulatory approval and market access.
• Interpreting results and providing statistical consultation for ad hoc analysis requests, including designing appropriate analyses to answer relevant questions.
• Taking accountability for ensuring quality in all planning, design, and execution of assignments associated with assigned protocols or projects.
• Effectively addressing questions from regulatory agencies, complying with BMS processes and SOPs, global and project standards, and responsible for quality of deliverables.

To be successful in this role, candidates should have at least 5 years of experience in pharmaceutical/R&D or related fields, managing statistical aspects of clinical development projects. They should also possess significant academic training in statistics, biostatistics, or relevant areas of study, as well as excellent communication skills in Japanese and English.