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 the head of Biostatistics, the successful candidate will be responsible for leading statistical efforts for multiple clinical studies.
The Associate Director, Biostatistics role will be responsible for overseeing statistical activities for multiple clinical studies and/or a clinical program, 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 and/or a clinical program
- 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 Investigator’s Brochure, project management plan, and other study/program-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; provide response to regulatory requests independently
- Support the preparation of publications, including manuscripts, posters and oral presentations
- 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 6 years of relevant clinical trial experience
- Knowledge of statistical methods for clinical trials
- In-depth Knowledge of FDA, EMA and ICH regulations and guidelines
- Experience with BLAs, MAAs and other regulatory submissions is a plus
- Proficient in statistical programming (SAS is required and R is a plus)
- Experience with trial design software (e.g., EAST)
- Good communication skills and ability to work with cross-functional study teams
- Good organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
- Good analytical and problem solving skills
- Positive, outgoing and collaborative attitude
- Ability to mentor junior statisticians
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.