United States onlyAbout bluebird bio
At bluebird every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, 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 bluebird days. We are doers, thinkers and collaborators who embrace and live by our values:
- Persist for Purpose
- Be Compassionate
- Stay humble and curious
- Keep it real
- Celebrate (sm)all wins
Our 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.
Sr./Principal, Statistical Programmer
ABOUT US
The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress and provides expert technical support to team members. In addition, the Principal Statistical Programmer fluently and routinely briefs management on accomplishments, status, and issues under their own initiatives, as well as being a designated member of clinical sub-team(s) in the role of project lead Statistical Programmer.
RESPONSIBILITIES
- Provides technical and project management 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 and project management 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
- 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
- Performs quality control checks of advanced SAS code for datasets and output produced by other Statistical Programmers
- Performs review on define.xml and create reviewers guide for ADaM datasets
- Review, maintain study documents per standard process
- Program, test, and document global utility programs and tools in accordance with standards and validation procedures
- Perform other duties as assigned
QUALIFICATIONS
- 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 and transparent communication skills and ability to influence across multiple functions
- MS in biostatistics or a related field, with 8+ years of experience in pharmaceutical industry, or BS in biostatistics or a related field, with 10+ years of experience in pharmaceutical industry
bluebird 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.
