Biostatistics Director (Hybrid)

Role Summary

Biostatistics Director (Hybrid) – The Director, Biostatistics will independently perform highly scientific statistical functions in support of the company’s Global Medicines Development and Affairs area on new and complex issues. The incumbent will provide independent strategic and technical contributions, with an emphasis on drug development processes, and has financial accountabilities and human resource responsibilities as a people manager.

Responsibilities

• Directs one or more projects including multiple clinical trials, observational studies, or real world data investigations, including presentations to internal senior review boards.
• Manage a team of direct reports including performance and development; mentor project team members and promote cross-functional collaboration.
• Provide expert understanding of modern drug discovery and development processes.
• Represent Biostatistics on cross-functional teams, set technical and scientific directions, and provide strategic input to elicit meaningful outcomes.
• Author Statistical Analysis Plans (SAPs) and development of related plans and documents to facilitate review and dissemination of study data/results.
• Lead collaboration with statistical programming and other functions to ensure high-quality delivery of tables, figures, and listings.
• Lead or contribute to external interactions with regulators, payers, and review boards.
• Author or co-author methodological or study-related publications and posters.
• Lead implementation of innovative designs and analysis methods; participate in SRF discussions of studies.
• Contribute to departmental working group efforts on technical and operational issues.
• Independently undertake new and highly complex issues requiring advanced analytical thought.
• Maintain and expand knowledge of related disciplines with a drug developer mindset.

Qualifications

• Prior staff management experience
• Project management and project team oversight
• 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 peers and managers
• Works well in a team and collaborates with non-statisticians
• NDA/MAA experience and direct dealings with USA/European regulators

Education

• Ph. D. in Statistics or Biostatistics
• Typically requires 10 years of experience with a Ph.D.