Assists in administrative task of Biostatistics function
Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents
Drives the design of innovative and efficient clinical trials. Develops trial designs that address study objectives that will supportregulatory approval and market access
Drives the interpretation of results
Reviews and/or inputs to regulatory documents
Develops collaborative relationships and work effectively with the GBDS Biostatistician, GBDS Biostatistics Lead, GBDS programmer and external vendors
Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions
Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol orproject
Effectively addresses questions from Regulatory Agencies
Compliant with BMS processes and SOPs, global and project standards, and responsible for quality of deliverables
Translates scientific questions into statistical terms and statistical concepts into layman terms
Keeps up-to-date with state-of-the art applied statistical methodology
Provides biostatisticians with trainings for improving knowledge and skills
Supports Biostatistics function continuous improvement
Supports and provides advices to cross-functional project teams
Negotiation with other functions to resolve any issues escalated by Biostatisticians
Qualifications
At least 5 years of Pharmaceutical/R&D or other related experience in planning and managing statistical aspects of clinical development
projects to support regulatory filings and market access.
Ability to work successfully within cross-functional teams leading to successful regulatory filings and approvals
Significant academic training in statistics, biostatistics or relevant areas of study
Understanding of the application of biostatistics to clinical trials data
Understanding of the regulatory guidance/guidelines
Good verbal and written communications skills in Japanese and English
Ability to organize multiple work assignments and establish priorities
