Sobre este puesto de Sr. Manager, Biostatistician / Programmer en Legend Biotech US
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.
Legend Biotech is seeking a Sr. Manager, Biostatistician/Programmer as part of the Clinical team based in Somerset, NJ.
Role Overview
The Sr. Manager, Biostatistician/Programmer plays a critical hands-on role in supporting Legend Biotech’s clinical development programs by transforming clinical trial data into high-quality analyses, tables, figures, and listings that inform decision-making. This role partners closely with clinical, translational, research stakeholders to deliver timely insights, conduct exploratory and ad hoc analyses, and deeply understand the medical and scientific questions underlying the data. The position requires strong programming expertise, data agility, intellectual curiosity, and the ability to work independently in a fast-moving biotech environment.
Key Responsibilities
- Develop, validate, and maintain high-quality Tables, Figures, and Listings (TFLs) to support ongoing clinical trials, interim analyses, and internal/external deliverables in compliance with study requirements and standards.
- Perform hands-on statistical programming and data manipulation to support planned and ad hoc analyses, addressing evolving clinical and scientific questions.
- Independently explore and interrogate clinical trial data to identify trends, anomalies, and insights that support clinical interpretation and decision-making.
- Collaborate closely with Biostatistics, Clinical Development, Clinical Operations, Data Management,
- Translational research and Medical teams to ensure alignment of analyses with protocol objectives and clinical intent.
- Apply a strong understanding of therapeutic area, disease biology, and clinical endpoints to translate data into meaningful scientific insights.
- Contribute to analysis datasets, program specifications, programming documentation, and quality control activities in accordance with internal standards and regulatory expectations.
- Support process improvement initiatives, including enhancing programming efficiency, standardization, and reproducibility across studies and programs.
- This role operates with a high degree of autonomy in determining programming approaches, exploratory analyses, and data interrogation strategies to answer clinical questions. The Sr. Manager may independently make decisions related to analysis methods, programming solutions, prioritization of tasks, and investigative follow-up of data issues. Escalation and alignment are expected for changes impacting study-level strategy, major deliverables, timelines with external visibility, or regulatory-facing outputs.
Requirements
- Master’s degree or PhD in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline.
- Demonstrated hands-on experience developing TFLs and performing ad hoc and exploratory analyses for clinical trials.
- Strong understanding of clinical trial design, clinical data structures, and the medical context behind analyses.
- Proven ability to work independently, manage ambiguity, and drive self-directed discovery from data.
- Experience supporting oncology and/or cell therapy programs is strongly preferred.
- Advanced proficiency in SAS for clinical trial analysis and reporting.
- Working knowledge of R for exploratory analyses and data visualization
- Strong experience with clinical data standards (e.g., SDTM, ADaM)
- Experience with or strong willingness to leverage AI-assisted programming tools to accelerate development, enhance code quality, and support efficient generation of Tables, Figures, and Listings (TFLs).
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Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.
EEO Statement
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.
