**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . **High-level 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 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. **Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as Transforming patients' lives through science™ , 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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility 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. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1578829 **Updated:** 2024-11-10 02:20:20.952 UTC **Location:** Otemachi-JP Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.