Associate Director, Statistical Programming

bluebird bio, Inc.•Somerville, MA

32d•Hybrid

About The Position

The successful candidate will be responsible for overseeing statistical programming activities within Genetix bio. The Associate Director, Statistical Programming role will be working closely with Biostatistics and clinical subteam, overseeing the vendor and working with internal resource to provide statistical programming support to data analysis for clinical trials. This individual may participate in departmental and cross functional technology development and process improvement initiatives. This is a full-time hybrid position (3 days a week) in our Somerville - Assembly Row, Massachusetts office. Potentially could consider remote.

Requirements

MS in biostatistics/epidemiology or a related field with at least 10 years (or BS with 12 years) of relevant experience
In-depth knowledge of FDA, EMA and ICH regulations and guidelines
Experience with BLAs, MAAs and other regulatory submissions
Display highly developed organizational leadership qualities, and proven to work on multi-tasks in an extremely fast-paced environment with changing priorities
Good communication skills and ability to work with cross-functional study teams
Good analytical and problem-solving skills
Positive, outgoing and collaborative attitude
Ability to mentor junior statistical programmers

Responsibilities

Work closely with Biostatistics, Data Management and the clinical subteam on Statistical Analysis of data to support clinical development, regulatory, and commercialization activities
Review CRF to ensure that data collected will meet the objectives and the requirements of statistical analyses
Review statistical analysis plans and shells for tables, figures and listings
Provide technical and project management leadership for internal statistical programmers or manage CROs to analyze and report complex data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format
Perform ad hoc and exploratory statistical analyses as needed
Support regulatory submissions as needed; provide response to regulatory requests independently
Support the preparation of publications, including manuscripts, posters and oral presentations
Provide oversight of CROs for outsourced statistical programming activities and lead QC activities for key results generated by CROs
Provides technical and project management leadership in SAS programs and applications designed to analyze and report complex data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format
Responsible for coaching, mentoring, and performance management of direct reports and junior programmers
Perform other duties as assigned