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
Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy programs. Reporting to the Senior Director of Biostatistics, Medical Affairs, the successful candidate will be responsible for overseeing statistical activities for scientific communications and contribute to reimbursement dossiers and real-world evidence (RWE) analyses. This individual will participate in departmental and cross functional technology development and process improvement initiatives.
HOW YOU’LL FLY
As a clinical development operations bird reporting to Sr. Director, Biostatistics, you'll help to bring more patients their bluebird days by:
- Oversee all Severe Genetic Disease (SGD) publication efforts from biostatistics perspective and in accordance with Good Publication Practices
- Work closely with scientific communication’s team on publication plans
- Participate and contribute to publications meetings with investigators
- Work closely with development statisticians and programmers to coordinate analyses needs for publication efforts
- Act as the author statistician for certain publication efforts, such as manuscripts requiring cross-program analyses taking the lead in application of statistical principles
- Provide support to Access, Value and Evidence Strategy team on reimbursement analyses as needed
- Provide support to real-world evidence (RWE) analyses as needed
- Work with internal statistical programmers or CROs to generate tables, figures and listings
- 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:
- PhD in biostatistics or a related field with at least 9 years (or MS with 12 years) of relevant clinical trial experience
- In-depth knowledge of statistical methods for clinical trials and observational studies
- Thorough understanding of FDA, EMA and ICH regulations and guidelines
- Extensive experience with trial design and clinical development plan
- Extensive experience with scientific communications and publication efforts
- Proficient in statistical programming (SAS is required, and R is a plus)
- Good communication skills and ability to work with cross-functional study teams
- Good organizational skills, sufficient to multi-task and work independently in an extremely fast-paced environment with changing priorities
- Good analytical and problem-solving skills
- Positive, outgoing and collaborative attitude
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.