Principal Biostatistician

1w1 week ago

ImmunityBio, Inc.

El Segundo, US · Full-time · $175,000 – $205,000

About this role

ImmunityBio, Inc. develops cell and immunotherapy products to strengthen the patient's natural immune system against cancer and infected cells. The Principal Biostatistician leads statistical strategy and provides expert guidance across clinical development programs. This role ensures rigorous, innovative, and regulatory-compliant statistical practices for complex studies.

Serve as lead statistician overseeing statistical aspects from study design through regulatory submission. Lead design of clinical trials including sample size calculations, interim analyses, and randomization procedures. Develop protocols, statistical analysis plans, and clinical study reports.

Partner with clinical, regulatory, data management, and medical affairs teams to align statistical approaches with program objectives. Communicate complex statistical concepts to non-statistical stakeholders including senior leadership. Participate effectively as a key member on clinical study teams.

Join a publicly traded biopharmaceutical company headquartered in Southern California. Work with a collaborative team across different areas of the company. Access professional development opportunities in a growing organization focused on cutting-edge immunotherapy.

Requirements

Subject matter expertise in design, management, technical oversight, and quality of statistical analyses for clinical trial data
Proficiency in clinical trial designs including sample size calculations, interim analyses, and randomization
Experience developing statistical analysis plans (SAPs) and writing statistical methodology for protocols and reports
Knowledge of data standardization efforts such as CDISC STDM/ADaM, CRF and database design, and e-submissions
Ability to proactively solve problems of statistical complexity and provide analytical insight on methodology
Current with new clinical trial designs and statistical methodology
Skills in mentoring and training junior staff in complex statistical methodology

Responsibilities

Serve as the lead statistician for one or more clinical programs, overseeing all statistical aspects from study design through regulatory submission
Lead the design of all clinical trials including sample size calculations, interim analyses, DMC activities, and randomization procedures
Lead the development of clinical trial protocols and clinical study reports; write statistical methodology section
Develop and review statistical analysis plans (SAPs), including methodology, sample size calculations, and interim analysis strategies
Guide and contribute to the creation, validation, traceability, reproducibility, and maintenance of analysis datasets and statistical outputs
Lead the electronic submission of clinical trial data to regulatory authorities
Partner with clinical, regulatory, data management, and medical affairs teams to align statistical approaches with program objectives
Communicate complex statistical concepts clearly to non-statistical stakeholders, including senior leadership and external collaborators

Benefits

Develop cutting-edge technology to transform lives of patients with cancer and infectious diseases
Join a publicly traded biopharmaceutical company with headquarters in Southern California
Work with a collaborative team across different areas of the company
Professional development opportunities in a growing company