Global Applied Statistics & Analytics Expert

Global Applied Statistics & Analytics Expert

Raritan, New Jersey, United States

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Role Overview

This position is a technical role in the global MSAT (GMSAT) organization. This individual will be part of the statistics and data science team in GMSAT that is responsible for all applied statistics and analytics scope in support of the approved Carvykti commercial process. At a technical level, the candidate will be required to support the broader Statistics group, develop statistical analyses to solve complex, inter-dependent, multi-variate / factor technical problems and execute statistical models to correlate various 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 report globally for all manufacturing nodes. Strong collaboration and partnership both internally and externally is required.

Key Responsibilities

• Develop and execute global statistical analyses
• Represent GMSAT 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 guidance for an expanding global manufacturing network for best-in-class CAR-T product
• Provide applicable cell biology or cell therapy related statistics expertise as dedicated support to cell therapy SMEs and the vector programs
• Provide advanced statistical analyses and development of simulation models (ie. predictive of risks to study failure)
• Develop and advance industry-leading statistical methods / tools, Machine Learning and AI tools
• Collaborate with site to gather data and reporting requirements and align tools / models / reporting
• Work with Validation function to establish global tiered data governance processes across manufacturing nodes
• Apply industry-standard methodologies specific to cell therapy products (eg, modified Nelson / Shewhart rules, equivalence vs. expectation approaches for comparability)
• Drive justification and alignment with key partners (eg. JnJ)

Requirements

Compensation

The anticipated base pay range is : $123,605 - $154,000 USD

Equal Opportunity

Legend Biotech is an equal opportunity / affirmative action employer. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex, age, disability, national origin, veteran status, or other protected characteristics. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

EEO / Voluntary disclosures

Legend Biotech may request voluntary self-identification information for government reporting purposes. Providing this information is voluntary and will not affect hiring decisions.

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