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Job Description

The Director, Biostatistics will independently perform highly scientific statistical functions in support of the company’s Cystic Fibrosis cell & gene therapies. The Director will drive breakthrough results with strategic and technical contributions, while possessing a deep knowledge of Biostatistics with a drug developer mindset. As a senior leader and people manager within the organization, they will play a crucial role in culture creation, team building, and coaching to direct reports and junior employees across the organization.

• Manage a team of direct reports including their performance and development. Mentors project team members and promotes effective team operation and cross-functional collaboration.
• Possesses an expert understanding of modern drug discovery and development processes.
• Represents Biostatistics as a member of cross functional teams, providing strategic input and expert technical guidance to elicit meaningful and/or productive outcomes.
• Sets the technical and scientific directions of the project(s).
• Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells.
• Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) to facilitate the review, summary, and dissemination of key study data/results.
• Leads collaboration with statistical programming and other functions to ensure high quality and technically sound delivery of TFLs.
• Leads or contributes to external interactions with regulators, payers, review boards, etc.
• Authors or co-authors methodological or study-related publications and posters.
• Leads implementation of innovative designs and analysis methods at the study or project level and participates in Statistical Review Forum (SRF) discussions of studies assigned to others.
• Contributes to departmental working group efforts on key various technical and operational issues.
• Independently undertakes new and highly complex issues requiring advanced analytical thought.
• Completes work in a resourceful, self-sufficient manner; conceptualizes alternative, and at times untested, approaches to achieve desired results.
• Maintains and expands in-depth knowledge of related disciplines with a drug developer mindset.

Education & Experience Required:

• Ph. D. in Statistics or Biostatistics.
• Typically requires 10 years of experience with a Ph.D. or 13 years of experience with a master's degree, or the equivalent combination of education and experience.

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