Principal Biostatistician

Benefits

Additional Information

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? - ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. - Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. - Work with a collaborative team with the ability to work across different areas of the company. - Ability to join a growing company with professional development opportunities. Position Summary The Principal Biostatistician will be the subject matter expert in design, management, technical oversight, and quality of statistical analyses and reporting of clinical trial data ensuring timelines and company strategic objectives are met. This position leads statistical strategy and provides expert guidance across our clinical development programs. In this role, you will serve as the primary statistical lead for complex studies and collaborate cross-functionally to ensure rigorous, innovative, and regulatory-compliant statistical practices. Essential Functions 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 of these documents. 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 the 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. Proactively solve problems of statistical complexity. Lead data standardization efforts (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions). Communicate complex statistical concepts clearly to non-statistical stakeholders, including senior leadership and external collaborators. Participate effectively as a key member on clinical study teams. Provides analytical insight on statistical methodology and advice to internal teams of accordingly. Keep current with new clinical trial designs and statistical methodology. As necessary, provide work direction, guidance, mentoring, influence and support to junior staff. Train junior staff in more complex statistical methodology. Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates. Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities. Education & Experience Bachelor's Degree in Statistics or Biostatistics is required with at least 10+ years of relevant experience is required; OR Masters's Degree in Statistics or Biostatistics is required with at least 8+ years of relevant experience is required. 5+ years of experience Biostatistician in the Biotech or Pharmaceutical industry is required. Experience as a Lead Biostatistician on several concurrent projects required. Experience with CDISC STDM/ADaM required. Knowledge, Skills, & Abilities Working knowledge of clinical research, Good Clinical Practices (GcP), and regulatory requirements/guidelines. Knowledge of adaptive trial designs, Bayesian methods, or complex innovative designs Proficient in SAS; familiar with sample size software such as nQuery or PASS. Ability to align statistical approaches with broader business and regulatory goals. Ability to influence decisions and mentor others Excellent analytical skills with meticulous attention to detail. Excellent English verbal and written communication skills; good organizational and interpersonal skills. Working Environment / Physica