Senior Manager, Biostatistics
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
Senior Manager, Biostatistics
Clinical Development Operations
Join bluebird bio’s enthusiastic and collaborative Clinical Development Operations (CDO) team by contributing to the overall success of our novel gene therapy development programs. Reporting to Senior Director of Biostatistics, the successful candidate will be responsible for leading statistical efforts for multiple clinical studies.
The Senior Manager, Biostatistics role will be responsible for overseeing statistical activities for multiple clinical studies, participating study designs and protocol development, ensuring compliance with SOPs to produce quality and timely deliverables. This individual will participate in departmental and cross functional technology development and process improvement initiatives.
About the Role:
- Serve as a lead statistician and manage statistical efforts for multiple clinical studies
- Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles
- Author statistical analysis plans for studies and/or ISS/ISEs, and author/edit shells for tables, figures and listings
- Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses
- Provide statistical input to data monitoring committee (DMC) charters, project management plan, and other study-level documents
- Work with statistical programmers or CROs to generate tables, figures and listings
- Support ongoing safety review and DMC review of the clinical development program/study teams
- Perform ad hoc and exploratory statistical analyses as needed
- Contribute to clinical study reports, including authoring of statistical sections and interpretation of the study results
- Support regulatory submissions as needed
- Support the preparation of publications, including manuscripts, posters and oral presentations
- Accountable for the performance and results at a study level. Ensures the implementation of biostatistics decisions and best practices
- Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs
- PhD in statistics or a related field with at least 3 years of relevant post marketing study or observational study experience or clinical study experience, or MS in statistics or equivalent with at least 6 years of relevant post marketing study or observational study experience or clinical study experience
- Advanced training in biostatistics and in-depth or breadth of expertise in an area of biostatistics. Has solid understanding of the following: statistical methods for clinical trials, FDA, EMA and ICH regulations and guidelines, CDISC requirement, and broad knowledge of related functions developed from considerable work experience.
- Writes statistical sections of protocols and SAP. Contributes to trial design and clinical development plan with supervision. Performs sample size calculation with existing software.
- Ability to lead team/workstream through navigating complex problems such as SOPs and WIs that have a broad impact on the business and successfully drives solutions
- Proven ability to effectively lead team/workstream with a meaningful impact on critical goals
- Participates in biostatistics goal setting as a subject matter expert as needed.
- Demonstrates solid presentation and communication skills in large group settings.
- Experience working cross functionally to achieve results.
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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