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Legend Biotech is seeking a Global Applied Statistics & Analytics Head as part of the Technical Operations team based Remote. 

Role Overview

This position is a lead technical role in the global MSAT organization. This individual will be responsible for all applied statistics and analytics scope in support of the approved Carvykti commercial process. This effort will extend to developing a center of excellence in cell therapy to drive global statistical approaches, methods and standards as well as the system and tools used in day to day commercial analyses. At a technical level, the candidate will be required to develop statistical analyses to solve complex, inter-dependent, multi-variate/factor technical problems and establish statistical models to correlate all process parameters. This effort is business critical to ensure that ongoing manufacturing processes are in a state of control and, additionally, adhere to guidelines established for CPV. In this role, it is expected to work closely with the site to gather data and reporting requirements and align tools/models/reporting mechanism globally for all manufacturing nodes. This effort would extend to development of end-to-end manufacturing data systems and include adopting leading GxP Part 11 tools from ingestion through reporting. Strong collaboration and partnership both internally and externally is required.

Key Responsibilities  

• Build Statistical Center of Excellence intended to drive global statistical approaches and methods
  
• Represent MSAT at joint statistical and analytical committee forums
  
• Partner closely with global manufacturing sites to solve complex, inter-dependent, multi-variate/factor technical problems and establish statistical models to correlate all process parameters
  
• Provide statistical and analytics mentorship/leadership for an expanding global manufacturing network for best-in-class CAR-T product
  
• Provides applicable cell biology or cell therapy related statistics expertise as dedicated support to cell therapy SMEs and the vector programs
  
• Develop statistical analyses
  
• Provides advanced statistical analyses and development of simulation models (ie. predictive of risks to study failure)
  
• Expertise and development of industry leading advanced statistical methods/tools, Machine Learning and AI tools
  
• Serves as primary SME for Health Authority interactions, responses to agency questions (RFIs), drafting industry guidelines, support for revisions to specification & critical limits, and training
  
• Works closely with the site to gather data and reporting requirements and aligns tools/models/reporting
  
• Develops plans to build out end-to-end manufacturing data systems. Scope includes industry leading GxP Part 11 compliant analytical tools and systems from ingestion through reporting
  
• Establishes global tiered data governance business processes to align across manufacturing nodes
  
• Employs industry leading methodologies and standard approaches specific to cell therapy products (ie. modified Nelson/Shewart rules, Equivalence vs. Expectation approaches for comparability)
  
• Drives justification and alignment with key partners (ie. JnJ)

Requirements

• B.S. required, Ph.D. preferred in technical discipline: engineering, science, or related field
• Minimum 12 years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable.
  
• Extensive experience in cell therapy commercial cGMP program with end-to-end know-how to manage process platform changes/improvements in a global manufacturing network and change management process.
  
• Candidate must have extensive experience in Cell Therapy tech transfer and/or MSAT.
• Extensive experience in a cross functional CMC team as a technical statistics and analytics representative supporting global commercial programs in cell therapy
  
• Extensive experience employing statistical and analytical methods to solve complex manufacturing issues in cGMP
  
• Experience in driving consistent statistical approaches and defending them to health authorities
  
• Experience in collaborating with internal technical SMEs to develop pragmatic solutions and deliverables around validation and comparability
  
• Industry leading knowledge in technology transfer, process comparability, CMC regulatory guidelines and manufacturing in cell therapy.
  
• Ability to think critically and demonstrated troubleshooting and problem-solving skills.
• Results driven with strong analytical, problem solving and critical thinking skills.
  
• Strong experience working in a cross-functional organization with multiple partners with competing priorities.
  
• Ability to plan, multitask, prioritize and be an effective and influential decision maker focused on action and implementation.
• Language: English

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