Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. Reporting to the Vice President of Clinical Development Operations, the successful candidate will be responsible for scientific oversight from a statistical perspective for a novel gene therapy products in multiple therapeutic areas including hemoglobinopathies, CNS and oncology.
In this leadership position, the Director, Biostatistics will support drug development activities and decision making encompassing Phase I-IV, registries and Investigator Sponsored Studies. This includes guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. Proven experience in strategic input into clinical development plans, and familiarity with regulatory standards and requirements. In addition, this person will select and oversee vendors and ensure they are performing to timeline and contractual agreements.
About the role:
- Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives
- Support Clinical Development Program teams as the biostatistical representative
- Responsibility for statistical content in support of clinical study designs and regulatory interactions
- Identify and implement emerging new ways of doing clinical development and new methodologies
- Manage biostatistics vendors in the design, and analysis of clinical studies using appropriate and innovative statistical methods
- Oversee vendors with respect to key performance indicators, metrics, and program level deliverables and timelines
- Travel domestic and international 10-15%
- Manage statistical programmers to deliver high quality statistical output for regulatory submissions, scientific abstracts/publications and clinical study reports
- Participate in establishment and development of department SOPs
- Maintain an active role in planning and preparation of regulatory submissions- briefing books and integrated summary documents
- Contribute to project budget/resource planning, re-forecasting, and program milestones, along with CPMs and Clinical Development Operations management
About you:
- Ph.D. in Statistics or Applied Mathematics
- 8-10 years of clinical research and drug development experience
- In-depth knowledge of methodologies applied in clinical trials with focus on early phase and registrational studies
- Experience with patient registries is a plus
- Extensive experience of interactions with regulatory agencies- US and Non-US
- Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development
- Strong verbal and written communication skills; experience operating effectively within cross-functional teams
- Flexible to changing priorities, detail-oriented, works well under pressure
- Ability to communicate statistical information to non-scientists, willingness to educate internal team
- Experience managing biometrics team, and resource planning
- Ability to work on multiple projects and achieve deliverables and timelines
- Excellent knowledge of GCP, ICH and FDA regulations
- “Do-what-it-takes” approach to problem solving.
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself