Bristol Myers Squibb Associate Director - Biostatistics in Princeton, New Jersey
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
Position Description and Responsibilities
This individual is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, the candidate will have the opportunity to serve as an indication lead supporting a particular indication of an asset.
Provides statistical methodological expertise across multiple therapeutic areas. The statistical methodology required may include, but are not limited to, adaptive designs, Bayesian analysis, network meta-analysis, sample size re-estimation, basket/platform designs, simulations and other methodology for innovative drug development.
Assists Biostatistics TA Head(s) in preparing a development strategy for the compound
Drives the design of innovative and efficient clinical trials to suit development strategy, including the selection of populations, endpoints and statistical analyses methodologies, in order to support regulatory approval and HTA assessment
Develops an effective partnership with the Biostatistics Asset Leads (BAL) to ensure the team’s ability to execute with quality in agreed to timelines. Provide statistical guidance/oversight to BAL at the strategic partner.
Demonstrate a high degree of knowledge regarding the assets and TA including knowledge of the underlying disease(s) and potential mechanism(s) of action, as well as current treatment landscape, up-to-date scientific literature and issues related to regulatory submission history of related products.
Collaborate effectively with colleagues from multiple drug development functions by driving statistical thinking, and proper data interpretation.
Ph.D. (or equivalent) in Statistics or related field. Seven years or more in Pharmaceutical/R&D or other related experience, including supporting regulatory filings in multiple regions (e.g. US, EU, Japan). Experience in planning for & participating in regulatory meetings, (e.g. US FDA). Expertise in general & cutting edge statistical/clinical trials methodology & ability to apply to relevant clinical development framework. Demonstrated ability in solving complex statistical problems. Excellent verbal and written communications skills. Ability to work successfully in cross-functional teams leading to successful global regulatory filings and approvals. Strong communication/presentation skills with ability to tailor the message to the key stakeholder for effective impact and influence. Ability to be flexible and adapt quickly to the changing needs of the organization. Ability to organize multiple work assignments and establish priorities. Demonstrated ability to operate and lead in a matrix organization, building successful working relationships and effective stakeholder management in an environment with multiple lines of authority and competing needs.
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, disability or protected veteran status.