Director, Statistical Programming

About Genetix Biotherapeutics

At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, 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 days. We are doers, thinkers and collaborators who embrace and live by our values:

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.

SUMMARY

The successful candidate will be responsible for leading Statistical Programming function within bluebird bio. The Director, Statistical Programming role will report to the Senior Director, Biostatistics and will be working closely with the Biostatistics and clinical sub team, overseeing vendors and working with internal resources to provide statistical programming support for data analysis of clinical trials and registry studies. This role also includes overseeing the programming function and providing both technical and managerial leadership. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office or Remote.

RESPONSIBILITIES

• Lead and manage all activities within the Statistical Programming function, ensuring integration with other departments.


• Provide technical leadership, timely delivery and strategic direction for regulatory submissions, including responses to health authority requests.


• Evaluate project plans and timelines, effectively allocate resources, and ensure timely delivery of key milestones.


• Manage, mentor and develop team members, fostering continuous improvement in processes and service delivery.


• Manage vendor relationships, ensuring quality and alignment with internal standards.


• Review and enhance standard operating procedures (SOPs) within Statistical Programming; contribute to SOPs and work instructions across related functions.


• Collaborate with Biostatistics, Data Management, and clinical teams on statistical analyses supporting development, regulatory, and commercialization efforts.


• Provide technical and project management leadership for internal programmers and CROs in the generation of Tables, Listings, and Figures, and in the preparation of SDTM and ADaM datasets in CDISC format.


• Conduct on ad hoc and exploratory statistical analyses as needed.


• Perform additional duties as assigned.

QUALIFICATIONS

• Master’s degree in Biostatistics or a related field with a minimum of 10 years (or Bachelor’s degree with 12+ years) of relevant experience


• Deep understanding of FDA, EMA and ICH regulations and guidelines


• Proven experience with regulatory submissions including BLAs and MAAs


• Strong organizational leadership skills with the ability to manage multiple priorities in a fast-paced environment


• Good communication skills and ability to work effectively with cross-functional teams


• Strong analytical and problem-solving capabilities.


• Collaborative, proactive, and positive attitude.


• Demonstrated ability to mentor and inspire confidence across teams.

Genetix 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.