Description

; including manage team/individuals or not
- The senior biostatistician contributes to trial design, protocol development, analysis planning, interpretation of results and preparation of regulatory submissions, and assists in administrative work of BDS-Japan.

Roles & responsibilities

Assists in administrative task of Biostatistics function
- Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical studyreports, 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

Requirments

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

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through scienceTM ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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