Offer summary

Qualifications:

PhD in statistics or a related field with at least 6 years of clinical trial experience, or MS with at least 9 years., Proficiency in statistical programming languages such as SAS; R is a plus., Knowledge of FDA, EMA, and ICH regulations and guidelines., Experience with trial design software and data standards like ADaM and SDTM..

Key responsibilities:

Lead statistical efforts for multiple clinical studies and contribute to protocol development.

Author statistical analysis plans and review data collection designs to meet study objectives.

Support safety reviews and contribute to clinical study reports and regulatory submissions.

Oversee outsourced statistical activities and ensure quality and compliance.

Job description

About bluebird bio

At bluebird 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 role, you become part of a company 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.

Associate Director, Biostatistics

ABOUT US

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.

RESPONSIBILITIES

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

QUALIFICATIONS

PhD in statistics or a related field with at least 6 years (or MS with at least 9 years) of relevant clinical trial experience, gene therapy experience is a plus
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)
Extensive experience with ADaM and SDTM
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

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.

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