Job Description

Company

QED

Role Title

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

Leadership Skills

  • 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.

Qualifications

  • 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

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