Senior Statistical Programmer

Bluebird Bio, Cambridge, Massachusetts, United States

integrated product platforms with broad therapeutic potential

Senior Statistical Programmer,

Biostatistics and Statistical Programming

Clinical Development Operations

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 Senior 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 Senior Statistical Programmer is a designated member of clinical subteam(s) in the role of project lead Statistical Programmer for a limited number of studies.

Key Responsibilities:

  • 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 complex clinical trial data and for electronic submissions of data in CDlSC format with minimal instruction or input from supervisor
  • Provides guidance on the resolution of highly complex clinical trial reporting problems within budget and time line constraints, while assuring high quality standards
  • 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

Technical and Communicative Skills:

  • Proven record of effective and successful project management tasks and skills
  • 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

Preferred Education and Experience:

  • S. (or equivalent degree) in statistics or related life science major and 3-7 years of relevant work experience or
  • S. (or equivalent degree) in statistics or related life science major and 5-9 years of relevant work experience

About Bluebird Bio

About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.

Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.