Statistical Programmer (Contract)
Clinical Development Operations
Do you improve every process and outcome you touch? Are you tired of having your great ideas shot down because "that's the way we've always done it"? If you are passionate about bringing pioneering therapies to patients with cancer and rare diseases and invested in improving the development process to bring products to patients in the best way we can, then bluebird bio is where you belong. Come bring your talents to our collaborative, creative, and passionate clinical development teams - we'll need your help as we develop the new evolution of Clinical Development Operations and #recodeforlife.
The Statistical Programmer 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 5-8 years of experience in pharmaceutical industry, or BS in statistics or related field, and 7-10 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, enough 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
About Bluebird Bio
Bluebird Bio offers products based on the transformative potential of gene therapy for patients with genetic and orphan diseases.