Description

Legend Biotech is seeking Global Applied Statistics & Analytics Expert as part of the Global MSAT team based Remotely.

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
• Provides applicable cell biology or cell therapy related statistics expertise as dedicated support to cell therapy SMEs and the vector programs
• 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
• Works closely with the site to gather data and reporting requirements and aligns tools/models/reporting
• Works in collaboration with Validation function to established 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, in technical discipline: statistics, engineering, science, or related field.
• Minimum 5 years of in a data analytics role employing statistical analyses, data science, machine learning, predictive modeling methods
• industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable.
• 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.
• Experience in cross functional teams as a technical statistics and analytics representative
• Extensive experience employing statistical and analytical methods to solve complex issues
• Experience in driving consistent statistical approaches and defending them to regulatory authorities is desirable
• 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.

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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.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Benefits:

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

EEO Statement

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.

Legend Biotech maintains a drug-free workplace.