Sr. Director Biostats and Data Analytics

Legend Biotech; Franklin Township (NJ); Remote; USD 130,000 - 190,000; Full time

Job summary

Join a forward-thinking company as a Senior Director of Biostatistics & Data Analytics, where you will lead a high-performing team and oversee biostatistics and data management for groundbreaking CAR-T cell therapy studies. In this key leadership role, you will shape data strategy, ensure regulatory compliance, and foster collaboration across clinical and technical teams. This position is perfect for an experienced professional with a strong background in clinical development and a passion for innovation in oncology and cell therapy. Embrace the opportunity to make a significant impact in a dynamic and inclusive environment.

Qualifications

• 15+ years in clinical development with oncology or cell therapy focus.
• Expertise in early-phase trials and adaptive designs.

Responsibilities

• Lead Data Analytics group overseeing biostatistics and data management.
• Collaborate with senior leadership to define data strategies.
• Ensure compliance with GCP, FDA, and EMA regulations.

Skills

Biostatistics expertise

Statistical programming (SAS, R)

Leadership skills

Clinical trial design

Data management

Regulatory compliance

Communication skills

Education

Ph.D. in Biostatistics or Statistics

Tools

SAS

R

CDISC/SDTM

Job description

Sr. Director Biostatistics and Data Analytics

Legend Biotech is seeking a Senior Director of Biostatistics & Data Analytics to join our Clinical Development team, remotely. This key leadership role will oversee all activities related to biostatistics, statistical programming, and data management, ensuring scientific and operational excellence in CAR-T cell therapy studies across early and late-stage development.

The ideal candidate will have extensive biostatistics expertise, proven leadership skills, and experience guiding clinical trial design and execution. Reporting directly to the Chief Medical Officer, this individual will shape data strategy, lead complex programs, and foster cross-functional collaboration across clinical, medical, regulatory, and technical teams.

Key Responsibilities

• Strategic & Functional Leadership
• Lead the Data Analytics group, overseeing biostatistics, programming, and data management for trials across indications including BCMA.
• Collaborate with senior leadership to define and implement data strategies.
• Manage, mentor, and develop a high-performing team.
• Serve as an internal expert on statistical methodology and development strategy.
• Represent the team in governance, regulatory, and partner engagements.
• Data Analytics Oversight
• Design and execute statistical strategies for studies, ensuring regulatory and scientific alignment.
• Review key study documents and contribute to analysis plans.
• Oversee data analysis activities and ensure methodological consistency.
• Provide statistical input for development and regulatory strategies.
• Cross-Functional Collaboration
• Work with clinical operations, medical affairs, regulatory, and other teams to support trials and data interpretation.
• Ensure seamless data flow and quality across departments.
• CRO and Vendor Oversight
• Guide CRO teams, monitor performance, and participate in vendor selection and budgeting.
• Quality, Compliance, and Documentation
• Ensure compliance with GCP, FDA, EMA, and other regulations.
• Support audit readiness and uphold data integrity standards.
• Key Relationships
• Collaborate with internal teams and external partners, maintaining independence and initiative.

Minimum Requirements

• Ph.D. in Biostatistics, Statistics, or related field.
• 15+ years in clinical development, with oncology or cell therapy focus.
• Leadership experience in cross-functional data teams.
• Expertise in early-phase trials, adaptive designs, and complex studies.
• Proficiency in SAS, R, CDISC/SDTM, and regulatory requirements.
• Track record with regulatory agencies and external partners.
• Strong organizational, analytical, and communication skills.
• Experience in small biotech or startup environments preferred.
• Excellent communication skills and GCP/ICH knowledge.

Legend Biotech is an equal opportunity employer committed to diversity and inclusion. We maintain a drug-free workplace.