Vice President, Biostatistics and Data Management
Summary of Key Responsibilities
- Build a highly effective statistics, statistical programming, and data management team by creating a vision, and recruiting, developing and retaining talented staff.
- Strategically partner with Clinical Development, Regulatory, and Clinical Operations expertise areas to provide drug development leadership on the design and execution of robust clinical development plans for novel therapeutics.
- Leverage advances in the field and, where appropriate, employ innovative trial designs & statistical methodologies in the design of efficient and effective clinical trials.
- Identify and implement solutions to statistical and data analysis issues related to clinical trials & regulatory submissions
- Effectively communicate and discuss complex statistical & drug development issues with R&D Leadership Team, and other Key Leaders, and influence portfolio strategy
- Be the accountable statistician for all regulatory interactions, and support analysis and assembly of data for a variety of regulatory activities, including the preparation of IND and NDA filings.
- Identify and lead efforts to improve data infrastructure and processes to support needs of Clinical Development, and adjacent expertise areas, such as pharmacovigilance and medical affairs.
- Ensure scientific integrity & timely availability of all data management and biostatistical deliverables.
- Actively manage resources and staffing to ensure a nimble and motivated team and efficient and high quality deliverables
- Lead continued development of global data standards
- Experience building effective teams; can integrate and manage conflict.
- Effective at attracting and developing talent to build a highly effective technical function.
- Adept and motivated to improve both strategic and operational excellence; willing to “roll up his/her sleeves and do what it takes” to achieve critical program deliverables.
- Rapid and agile decision-maker who can lead the team in soliciting and analyzing multiple points of view. Can exert good judgment regarding when to elevate issues above the team level.
- Possesses effective communication skills; is an active listener and fosters a team climate of open and honest communication.
- Motivates others by creating a climate in which team members strive to do their best; invites input from others and shares ownership for team success.
- Demonstrates strong organizational/presentation skills.
- Fosters trust through strong partnership and collaboration with all team/sub-team members and leaders/stakeholders.
- Excellent interpersonal skills with particular emphasis on communication, influencing, & relationship building.
- Ph.D. in Biostatistics or Statistics with 10+ years biotechnology/pharmaceutical biostatistics experience
- Experience managing teams of Statisticians, Data Managers, and SAS Programmers
- Ability to partner and provide strategic depth in drug development area
- NDA submission experience required
- Experience across all areas of development, from FIH through filing and post-marketing across a variety of therapeutic areas desirable
- Experience interacting with U.S. and Global regulatory authorities, including NDA/BLA/MAA filings