Legend Biotech
Global Applied Statistics & Analytics Expert
Legend Biotech is seeking a Global Applied Statistics & Analytics Expert as part of the Global MSAT team based remotely. Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases, with a focus on autologous and allogenic CAR-T, TCR-T, and NK cell-based immunotherapies. The organization collaborates with Janssen to jointly develop and commercialize cilta-cel for multiple myeloma. Role Overview This technical role in the global MSAT (GMSAT) organization supports all applied statistics and analytics for the approved Carvykti commercial process. The candidate will develop statistical analyses to solve complex, inter-dependent, multivariate problems, execute models to correlate process parameters, and ensure manufacturing processes are in a state of control while adhering to CPV guidelines. The role requires close collaboration with manufacturing sites to gather data and report globally for all manufacturing nodes, with strong internal and external partnership. Key Responsibilities Develop and execute global statistical analyses Represent GMSAT at joint statistical and analytical committee forums Partner with global manufacturing sites to solve complex, inter-dependent, multivariate problems and establish statistical models to correlate process parameters Provide statistical and analytics guidance for a expanding global manufacturing network for best-in-class CAR-T product Provide applicable cell biology or cell therapy statistics expertise as dedicated support to cell therapy SMEs and vector programs Provide advanced statistical analyses and development of simulation models (predictive of risks to study failure) Develop industry-leading advanced statistical methods/tools, including Machine Learning and AI tools Collaborate with sites to gather data and align reporting tools/models Work with Validation to establish global tiered data governance across manufacturing nodes Apply cell therapy-specific methodologies (e.g., Nelson/Shewhart rules, equivalence vs. expectation for comparability) Drive justification and alignment with key partners (e.g., JnJ) Requirements B.S. in statistics, engineering, science, or related field Minimum 5 years in a data analytics role with statistical analyses, data science, machine learning, predictive modeling Industrial biologics CMC development or manufacturing experience; CAR-T experience desired Experience in cell therapy commercial cGMP programs with end-to-end knowledge of process platform changes in a global manufacturing network Extensive experience in cell therapy tech transfer and/or MSAT Experience in cross-functional teams as a technical statistics and analytics representative Experience employing statistical/analytical methods to solve complex issues and defend approaches to regulatory authorities is desirable Experience collaborating with internal SMEs to develop pragmatic validation and comparability solutions Industry-leading knowledge in technology transfer, process comparability, CMC regulatory guidelines, and manufacturing in cell therapy Critical thinking, troubleshooting, and strong analytical skills Effective cross-functional collaboration and prioritization in a multi-partner environment Ability to plan, multitask, and drive action-oriented decisions The anticipated base pay range is $123,605 USD - $154,000 USD. Benefits Health, dental, and vision insurance Paid 401(k) with company match Flexible Spending Account and Health Savings Account Life, AD&D, short- and long-term disability insurance Paid parental leave and generous PTO (vacation, personal, sick days, holidays) Pet, critical illness, accident, and hospital indemnity insurance Commuter benefits and employee well-being resources EEO Statement Legend Biotech is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend Biotech maintains a drug-free workplace.
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Legend Biotech is seeking a Global Applied Statistics & Analytics Expert as part of the Global MSAT team based remotely. Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases, with a focus on autologous and allogenic CAR-T, TCR-T, and NK cell-based immunotherapies. The organization collaborates with Janssen to jointly develop and commercialize cilta-cel for multiple myeloma. Role Overview This technical role in the global MSAT (GMSAT) organization supports all applied statistics and analytics for the approved Carvykti commercial process. The candidate will develop statistical analyses to solve complex, inter-dependent, multivariate problems, execute models to correlate process parameters, and ensure manufacturing processes are in a state of control while adhering to CPV guidelines. The role requires close collaboration with manufacturing sites to gather data and report globally for all manufacturing nodes, with strong internal and external partnership. Key Responsibilities Develop and execute global statistical analyses Represent GMSAT at joint statistical and analytical committee forums Partner with global manufacturing sites to solve complex, inter-dependent, multivariate problems and establish statistical models to correlate process parameters Provide statistical and analytics guidance for a expanding global manufacturing network for best-in-class CAR-T product Provide applicable cell biology or cell therapy statistics expertise as dedicated support to cell therapy SMEs and vector programs Provide advanced statistical analyses and development of simulation models (predictive of risks to study failure) Develop industry-leading advanced statistical methods/tools, including Machine Learning and AI tools Collaborate with sites to gather data and align reporting tools/models Work with Validation to establish global tiered data governance across manufacturing nodes Apply cell therapy-specific methodologies (e.g., Nelson/Shewhart rules, equivalence vs. expectation for comparability) Drive justification and alignment with key partners (e.g., JnJ) Requirements B.S. in statistics, engineering, science, or related field Minimum 5 years in a data analytics role with statistical analyses, data science, machine learning, predictive modeling Industrial biologics CMC development or manufacturing experience; CAR-T experience desired Experience in cell therapy commercial cGMP programs with end-to-end knowledge of process platform changes in a global manufacturing network Extensive experience in cell therapy tech transfer and/or MSAT Experience in cross-functional teams as a technical statistics and analytics representative Experience employing statistical/analytical methods to solve complex issues and defend approaches to regulatory authorities is desirable Experience collaborating with internal SMEs to develop pragmatic validation and comparability solutions Industry-leading knowledge in technology transfer, process comparability, CMC regulatory guidelines, and manufacturing in cell therapy Critical thinking, troubleshooting, and strong analytical skills Effective cross-functional collaboration and prioritization in a multi-partner environment Ability to plan, multitask, and drive action-oriented decisions The anticipated base pay range is $123,605 USD - $154,000 USD. Benefits Health, dental, and vision insurance Paid 401(k) with company match Flexible Spending Account and Health Savings Account Life, AD&D, short- and long-term disability insurance Paid parental leave and generous PTO (vacation, personal, sick days, holidays) Pet, critical illness, accident, and hospital indemnity insurance Commuter benefits and employee well-being resources EEO Statement Legend Biotech is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend Biotech maintains a drug-free workplace.
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