Sr.Process Statistician, MSAT
Bluebird Bio, Cambridge, MA
integrated product platforms with broad therapeutic potential
Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. The Data systems and analytics organization at bluebird bio is a team of engineers and data analysts responsible for the non-clinical statistical and data analysis support 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
- Collaborates with Process and analytical development team and QC to implement method performance monitoring and reference standard qualification
- 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
- Provides statistical and data analysis SME support for complex data analysis requests, such as critical investigations, stability trending or yield improvement initiatives
- Conduct statistics training as required including application of basic and advanced statistics
- 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
- MS or PhD degree in an engineering, mathematics/statistics or scientific field with demonstrated capability in applied data science.
- 5+ 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
- Experience articulating business questions and using mathematical and programmatic solutions to arrive at an answer
- Working knowledge of GMP requirements of biopharmaceutical manufacturing is preferred
- 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
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.
Innovative, fast-paced, challenging.. we're everything you want in a workplace.