ABOUT THE NEST
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
ABOUT THE FLOCK
The Clinical Development Operations flock is all about getting stuff done and working together! We are driven by by contributing to the overall success of our novel gene therapy programs. Reporting to the head of Biostatistics, the successful candidate will be responsible for leading statistical efforts for multiple clinical studies. Come work with an enthusiastic group of birds that loves rising to the challenge much as we do!
HOW YOU’LL FLY
The Associate Director, Biostatistics 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. This individual will participate in departmental and cross functional technology development and process improvement initiatives.
As a Clinical Development Operations bird), reporting to the Head of Biostatistics 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 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
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 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
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
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.