Sr. Director Biostatistics and Data Analytics

Legend Biotech USA; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

An established industry player is on the lookout for a dynamic Senior Director of Biostatistics & Data Analytics to spearhead its Data Analytics function. This pivotal role involves leading a high-performing team, shaping the data strategy for CAR-T cell therapy studies, and ensuring operational excellence across clinical trials. With a focus on oncology and cell therapy, the ideal candidate will leverage their deep biostatistics expertise to drive cross-functional collaboration and regulatory compliance. If you are a strategic thinker with a passion for data and leadership, this is your chance to make a significant impact in a forward-thinking organization.

Qualifications

• 15+ years of experience in clinical development, focusing on oncology and cell therapy.
• Demonstrated leadership of cross-functional data analytics teams.

Responsibilities

• Lead the Data Analytics group, overseeing Biostatistics, Programming, and Data Management.
• Collaborate with Clinical Operations and Regulatory Affairs to support trial execution.

Skills

Biostatistics

Statistical Programming

Data Management

Leadership

Communication Skills

Project Management

Problem-Solving

Regulatory Knowledge

Education

Ph.D. in Biostatistics or Statistics

Tools

SAS

R

MS Office Suite

Job description

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

• S trategic & 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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,"conclusion":"
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 law.

Legend Biotech maintains a drug-free workplace.

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 law.

Legend Biotech maintains a drug-free workplace.