Bristol-Myers Squibb Company

Manager, Biostatistics

Princeton, NJ, US
Oct 07, 2018
Required Education
Position Type
Full time
Position Description and Responsibilities

This individual is a member of cross-functional development teams and will support Biostatistics TA Head to provide expert and independent statistical leadership in support of an asset(s) within a Therapeutic Area(s) (TA), including guidance on statistical methods, appropriate study design, data analytical approaches and interpretation of results for an asset(s)
  • Support the Biostatistics TA Head to ensure execution of development strategy with respect to development of asset specific methodology, study designs, data collection, reporting and interpretation as well as regulatory and HTA interactions
  • 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.
  • Influence the broader organization with respect to innovation in clinical study design.

Position Requirements

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.