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. The Contractor Manager, Statistical Programmer provides Statistical Programming technical leadership and support to team members. He/She delegates tasks appropriately and tracks progress, may also construct estimates of project resource requirements and time lines and routinely briefs management on accomplishments, status of projects, and any issues. In addition, the Manager, Statistical Programming is a designated member of clinical subteam(s) in the role of project lead Statistical Programmer for a limited number of studies.
About the Role:
- Effectively designs and codes SAS programs for assigned project(s), consistently meeting objectives of the project
- Codes complex SAS programs for applications designed to analyze and report clinical trial data and for electronic submissions of data in CDlSC format with minimal instruction or input from supervisor
- Facilitates and maintains relationships with external vendors and manages vendor and sponsor relationships for data transfer, analysis, reporting, and CDlSC data submission tasks
- Performs quality control checks of advanced SAS code and output produced by other Statistical Programmers
- Responsible for maintaining excellent working knowledge of medical data, the design and phases of clinical trials, statistics, relevant regulatory requirements, and the pharmaceutical industry
- Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)
- May conduct briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMEA, et cetera), on assigned projects
- Manages project timelines and schedules of specific phases of projects and contracts with internal personnel and outside customer representatives.
- May supervise other statistical programming staff
- Performs other duties as assigned
- MS in biostatistics or a related field, with 3-7 years of experience in pharmaceutical industry, or BS in statistics or related field, and 5-9 years of experience in pharmaceutical industry.
- Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
- Demonstrates advanced knowledge of electronic submissions and CDlSC
- Displays highly advanced knowledge regarding software validation and system development life cycle concepts
- Communicates effectively in verbal presentations and written technical reports to both internal
- and external customers 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.