Director, Statistical Programming

About Genetix BiotherapeuticsAt Genetix every role has meaning, every team member is respected. When you join Genetix Biotherapeutics, 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 and better days. We are doers, thinkers and collaborators who embrace and live by our values:Persist for PurposeBe CompassionateStay humble and curiousKeep it realCelebrate (sm)all winsOur 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. SummaryThe 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. ResponsibilitiesLead 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. QualificationsMaster's degree in Biostatistics or a related field with a minimum of 10 years (or Bachelor's degree with 12+ years) of relevant experienceDeep understanding of FDA, EMA and ICH regulations and guidelinesProven experience with regulatory submissions including BLAs and MAAsStrong organizational leadership skills with the ability to manage multiple priorities in a fast-paced environmentGood communication skills and ability to work effectively with cross-functional teamsStrong analytical and problem-solving capabilitiesCollaborative, proactive, and positive attitudeDemonstrated 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. DetailsSeniority level: DirectorEmployment type: ContractJob function: Marketing, Public Relations, and Writing/Editing #J-18808-Ljbffr

Created: 2025-09-21