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Sr. Director Biostatistics and Data Analytics

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.  

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 Sr. Director Biostatistics and Data Analytics as part of the Clinical Development team based Remotely. 

Role Overview

Legend Biotech is seeking a dynamic and strategic Senior Director of Biostatistics & Data Analytics to lead and build out the Data Analytics function across our BCMA and broader pipeline programs. This highly visible role will be responsible for overseeing all Biostatistics, Statistical Programming, and Data Management activities, ensuring the highest standards of scientific and operational excellence for our CAR-T cell therapy studies in for early and late-stage development.

The ideal candidate brings deep biostatistics expertise, proven leadership, and hands-on experience in guiding clinical trial design and execution. Reporting directly to the Chief Medical Officer, this individual will play a key role in shaping Legend’s data strategy, leading complex development programs, and driving cross-functional collaboration across clinical, medical, regulatory, and technical functions

Key Responsibilities  

  • Strategic & Functional Leadership
    • Serve as the head of the Data Analytics group, overseeing Biostatistics, Programming, and Data Management functions for Legend’s clinical trials across multiple indications, including BCMA and other pipeline assets.
    • Partner closely with the CMO and senior leadership to define and execute data strategy across the development portfolio.
    • Lead, mentor, and develop a high-performing team of statisticians, programmers, and data managers.
    • Serve as a key internal expert on statistical methodology and clinical development strategy.
    • Represent Biostatistics and Data Analytics in internal governance meetings and external regulatory, partner, and advisory engagements.
  • Data Analytics Oversight
    • Lead the design and execution of statistical strategies across early- and late phase studies ensuring alignment with regulatory, scientific, and operational objectives
    • Review and contribute to key study documents including protocols, SAPs, CRFs, CSRs, DMC charters, and statistical deliverables
    • Oversee all aspects of data analysis including interim, final, and ad hoc analyses in collaboration with internal and external statistical programmers.
    • Ensure consistency and quality across studies by standardizing methodologies and statistical approaches.
    • Provide statistical input on the Clinical Development Plan (CDP) and overall regulatory strategy
  • Cross-Functional Collaboration
    • Collaborate closely with Clinical Operations, Medical Affairs, Regulatory Affairs, CMC, Preclinical, and Safety to support trial execution and data interpretation.
    • Provide biostatistical and data expertise to cross-functional teams and ensure integrated data flow across departments.
    • Work with internal stakeholders and CRO partners to ensure accurate, timely, and compliant data deliverables.
  • CRO and Vendor Oversight
    • Provide oversight and strategic guidance to CRO statisticians, data managers, and programmers to ensure quality and timeliness of deliverables.
    • Develop KPIs, metrics, and dashboards to monitor CRO and vendor performance.
    • Participate in vendor selection, contracting, and budget planning for Data Analytics vendors
  • Quality, Compliance, and Documentation
    • Ensure that statistical and data management activities are conducted in accordance with ICH-GCP, FDA, EMA, and other applicable regulations.
    • Support audit readiness across studies, including oversight of Trial Master File (TMF) completeness.
    • Champion best practices in data integrity, documentation, and analysis reproducibility.
  • Key Relationships
    • Working closely with the Biometrics/Data Analytics team, Medical Director, Clinical Scientist, Sr. Director of Clinical Operations/Data Analytics and different cross-functional teams including safety, study monitoring and coordinators, data management, biostatistics, bio analytics, manufacture, supply chain, regulatory, project management, medical affairs, and quality.
    • Excellent team player but also independently without significant oversight.
    • Strong Self-Starter and hardworking individual, willingness and ability to fill functional gaps in a small organization.

Requirements

  • Ph.D. in Biostatistics, Statistics, or related discipline required.
  • 15+ years of experience in clinical development, with a strong emphasis on oncology and/or cell therapy.
  • Demonstrated leadership of cross-functional data analytics teams (biostats, programming, data management).
  • Experience leading early-phase trials and complex study designs (e.g., adaptive designs, basket/umbrella trials)
  • Deep understanding of statistical software (e.g., SAS, R), data standards (CDISC/SDTM), and FDA/EMA regulatory requirements.
  • Proven track record of successful engagement with regulatory agencies and external partners.
  • Strong organizational, analytical, and problem-solving skills; able to manage multiple priorities in a fast-paced environment.
  • High emotional intelligence and strong communication skills, capable of translating complex statistical concepts for non-technical audiences.
  • Experience in a small biotech/startup environment preferred; comfortable wearing multiple hats.
  • Effective oral, written and interpersonal communication skills.
  • Strong communication skills.
  • SOP development preferred
  • Strong organizational and project management skill and the ability to multitask
  • Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project)
  • Oncology Therapeutic Experience preferred
  • Excellent working GCP, FDA, and ICH Guidelines 

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The anticipated base pay range for this is: $248,615 - $341,846 USD. 

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.

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