Legend Biotech · 9 hours ago
Global Applied Statistics & Analytics Head
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
12+ years exp
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Hiring Manager
Joseph Kady
Insider Connection @Legend Biotech
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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)
Qualification
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Required
B.S. required in technical discipline: engineering, science, or related field
Minimum 12 years of industrial biologics CMC development or manufacturing experience
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
Preferred
Ph.D. preferred in technical discipline: engineering, science, or related field
CAR-T experience is highly desirable
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Matched 401K
Flexible Spending Account
Health Savings Account
AD&D Insurance
Short-Term Disability
Long-Term Disability
Paid Maternity Leave
Paid Paternity Leave
Pet Insurance
Critical Illness Insurance
Hospital Indemnity Insurance
Accident Insurance
Legal Insurance
Commuter Benefits
Employee Assistance Program
Company
Legend Biotech
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
1001-5000 employees
H1B Sponsorship
Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (8)
2022 (10)
2021 (9)
2020 (12)
Funding
Current Stage
Public CompanyTotal Funding
$750.45M2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-11-27IPO
Leadership Team
Ying Huang
Chief Executive Officer
Lori Macomber
CFO
Recent News
Labiotech.eu
2024-12-16
2024-12-16
2024-12-11
Company data provided by crunchbase
