Responsible for overseeing statistical programming activities for real-world evidence (RWE) activities across all programs within bluebird bio. Responsibilities include: serve as a lead statistical programmer for real-world evidence (RWE) activities across all programs within bluebird bio; work closely with Biostatistics, Data Management and the RWE group on Statistical Analysis of data from RWE to support regulatory, clinical development, and commercialization activities; review statistical analysis plans and shells for tables, figures and listings; review data collection templates to ensure that data collected will meet the objectives and the requirements of statistical analyses; 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 CDISC 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 QC key results generated by CROs; provide 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 CDISC format; and perform other duties as assigned.
Must have MS in statistics/biostatistics, information systems or a related field and 7 years of experience with statistical programming in the field of life sciences/clinical research. Experience must include the following: creating TLFs (Tables, listings, Figures) using SAS programs; creating SDTM and ADaM datasets using industry standard format such as CDISC (Clinical Data Interchange Standards Consortium); creating global standard SAS macros to automate tasks such as performing analyses or plotting data; experience with regulatory submissions for drug product approvals, such as BLAs and MAAs; and working with other professionals such as statisticians, medical directors, and drug safety teams. Will also accept a BS and 9 years of experience.