Director, Biostatistics

About This Role

The Director, Biostatistics independently performs highly scientific statistical functions in support of the company’s Global Medicines Development and Affairs (GMDA) area on new and complex issues. The role involves completing work in a resourceful, self-sufficient manner and creating alternative approaches to achieve desired results if needed. The Director provides independent strategic and technical contributions and possesses excellent knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

Responsibilities

• Direct one or more projects including multiple clinical trials, observational studies, or real world data (RWD) investigations, including presentations to the Peer Protocol Review Committee (PPRC) or other internal senior review boards.
• Manage a team of direct reports, including their performance and development, mentoring project team members and promoting effective team operation and cross-functional collaboration.
• Represent Biostatistics as a member of cross-functional teams, providing strategic input and expert technical guidance to elicit meaningful and/or productive outcomes.
• Author study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells, and develop Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP).
• Lead collaboration with statistical programming and other functions to ensure high quality and technically sound delivery of TFLs.
• Lead or contribute to external interactions with regulators, payers, review boards, etc.
• Author or co-author methodological or study-related publications and posters.
• Lead implementation of innovative designs and analysis methods at the study or project level and participate in Statistical Review Forum (SRF) discussions of studies assigned to others.
• Contribute to departmental working group efforts on key various technical and operational issues.
• Independently undertake new and highly complex issues requiring advanced analytical thought.
• Maintain and expand in-depth knowledge of related disciplines with a drug developer mindset.

Requirements

• Ph.D. or master's degree 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.
• Expertise with SAS and R statistical software.
• Demonstrated expertise in advanced/complex statistical methods used in drug development.
• Deep skill in critical thinking and logical problem-solving.
• Excellent written and verbal communication skills with the ability to influence opinions of peers and managers.
• Experience with NDA/MAA and direct dealings with USA/European regulators.