On January 11, 2021, we announced our intent to separate our severe genetic disease and oncology businesses into differentiated and independent publicly traded companies. We will retain focus on severe genetic disease (SGD) and will launch our oncology business (“Oncology Newco”) as a new entity, with the completed transition expected by the end of 2021.

 

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.

Apply for this Job

* Required

  
  


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at bluebird bio are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.