Join bluebird bio’s enthusiastic and collaborative Clinical Development Operations (CDO) team by contributing to the overall success of our novel gene therapy development programs. Reporting to an Associate Director of Statistical Programming, the successful candidate should be exceptionally experienced in directing and coordinating the activities of Statistical Programming staff assigned to projects. The Contractor Senior Manager works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members.
About the Role:
- Provides technical leadership in SAS programs and applications designed to analyze and report complex clinical trial data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format, with minimal instruction or input from supervisor
- Provides technical leadership to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission
- Provides leadership to ensure compliance with company SOP'S and FDA/ICH/GCP regulations
- Regularly works with advanced features of SAS including interfacing ability with other software applications and operating system tools
- Conducts briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMA, et cetera) for projects with more significant consequences and impact
- Participates on high impact departmental and cross-functional teams working on standard operating procedures, process improvements, system validation, and acquisition, customization, and integration of new tools and technologies
- Performs other duties as assigned
- MS in biostatistics or a related field, with 7 years of experience in pharmaceutical industry, or BS in statistics or related field, and 9 years of experience in pharmaceutical industry.
- Experience with BLAs, MAAs and other regulatory submissions is a plus
- Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
- Displays highly evolved written and oral presentation skills that enable him/her to disseminate the importance of complex technical solutions more articulately and persuasively
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
- Excellent and transparent communication skills and ability to influence across multiple functions.
- Positive, outgoing and collaborative attitude
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
12 Months and can be renewed
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.