United States onlyABOUT THE NEST
The nest is a place where every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, you're not just landing a new gig, you become part of a flock that's pursuing curative gene therapies to give patients and their families more bluebird days. We are doers, thinkers and collaborators who embrace and live by our values:
- Persist for Purpose
- Be Compassionate
- Stay humble and curious
- Keep it real
- Celebrate (sm)all wins
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
ABOUT THE FLOCK
The Statistical Consultant role will be responsible for overseeing statistical activities for multiple clinical studies and/or a clinical program, participating in study designs and protocol development, ensuring compliance with SOPs to produce quality and timely deliverables.
HOW YOU’LL FLY
You’ll help to bring more patients their bluebird days by:
- 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 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 interactions and submissions as needed
- Support the preparation of publications, including manuscripts, posters and oral presentation
WHAT YOU’LL BRING
You’re the bird we’re looking for if you have:
- PhD in statistics or a related field with at least 12 years of relevant clinical trial experience, gene therapy experience is a plus
- In-depth knowledge of statistical methods for clinical trials, Bayesian methodology application to small sample is a plus
- Thorough understanding of FDA, EMA and ICH regulations and guidelines
- Extensive experience with trial design and clinical development plan
- Experience with BLAs, MAAs and other regulatory submissions
- Proficient in statistical programming (SAS is required, and R is a plus)
- Experience with trial design software (e.g., EAST)
- Extensive experience with SDTM and ADaM
- 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
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
