Process Statistician

Location
Cambridge, MA, United States
Posted
Nov 15, 2018
Ref
1167599
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Full time
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. The Manufacturing Science and Technology (MSAT) organization at bluebird bio is a team of scientists and engineers responsible for the technical support and oversight of late stage and commercial manufacturing processes for small molecules, oligonucleotides, lentiviral-based vectors and stem and immune cell-based therapies across internal and external manufacturing sites.

The focus of the Process Statistician role is to assess and optimize bluebird bio's manufacturing processes across our integrated product platforms and late-stage pipeline. The position will develop and deploy appropriate statistical approaches to the challenges of process development, technology transfer, process validation, manufacturing, continued process verification (CPV) and statistical process control. The Process Statistician will lead the design, development and implementation of process analytics solutions that improve the robustness, consistency, yield and scalability of gene therapy manufacturing processes.

About the role:
  • Works cross-functionally across Program/CMC Teams, Process Development, Manufacturing, Supply Chain, Regulatory Sciences and Quality to provide technical assessment for engineering and process changes in a cGMP environment
  • Demonstrates solid understanding and use of statistical principles and practices to solve a range of complex problems
  • Performs complex statistical data analysis independently
  • Co-authors, reviews and/or approves procedures, protocols, technical reports and regulatory submissions focusing on statistical analysis of manufacturing process data
  • Build and prototype tools (dashboards, apps) to provide process analytics insights. Develop comprehensive understanding of bluebird bio data structures and metrics, advocating for changes where needed for process improvements
  • Implement machine learning applications through integration of multiple data sources
  • Leverage large datasets to conduct end-to end analytics projects that include data gathering and requirements specifications, processing, analytics, ongoing deliverables, and presentations
  • Make business recommendations (cost-benefit, forecasting, scenario analysis) with effective presentation of findings to multiple stakeholders at appropriate level
  • Contribute to establishing a robust data science strategy by providing recommendations related to data engineering, analytic platforms, analysis plans, and other relevant areas of data science
  • Provides statistical and data analysis SME support for complex data analysis requests, such as critical investigations, stability trending or yield improvement initiatives
  • Collaborates with global and site functions to identify areas of improvement for yield and robustness and to build organizational capabilities in statistical analysis of process data

About you:
  • MS/PhD degree in an engineering, mathematics/statistics or scientific field with demonstrated capability in applied data science.
  • 3+/1+ years of work experience in biotechnology role (e.g. as a statistician, statistical programmer, data analyst, data scientist, computational biologist, bioinformatician)
  • Experience with programming (e.g. JMP, R, MATLAB, Python) and database languages (e.g. SQL), as well as data visualization tools (e.g. Spotfire)
  • Experience with statistical data analysis such as linear/non-linear multivariate models and hypothesis testing
  • Applied experience with implementing machine learning solutions
  • Experience articulating business questions and using mathematical and programmatic solutions to arrive at an answer
  • Demonstrated skills in selecting the right statistical tools for a range of complex data analyses
  • Strong writing, editing and presentation skills required
  • Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
  • Independently motivated, detail-oriented and good problem-solving ability
  • Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
  • Excellent communications skills and ability to influence across multiple functions.
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself