Senior Biostatistician

About this role

Company Overview ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.

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 Senior Biostatistician will be the subject matter expert in the design, management, technical oversight, and quality of statistical analyses and reporting of clinical trial data ensuring timelines and company strategic objectives are met.

Essential Functions • Lead and contribute to the design of phase I-III clinical trials including sample size calculations, interim analyses, DMC activities, and randomization procedures. • Lead and contribute to the development of clinical trial protocols and clinical study reports; write statistical methodology section of these documents. • Develop and prepare statistical analysis plans, statistical output shells, and analysis dataset specifications. • Guide and contribute to the creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs. • Contribute to the electronic submission of clinical trial data to regulatory authorities. • Proactively solve problems of statistical complexity. • Provide input or 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). • 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 as assigned to support business needs and provide developmental opportunities.

Education & Experience • Bachelors’ Degree in Statistics or Biostatistics is required with at least 7+ years of relevant experience is required;  OR • Masters’s Degree in Statistics or Biostatistics is required with at least 5+ years of relevant experience is required. • 3+ years of experience Biostatistician in the Biotech or Pharmaceutical industry is required.

Knowledge, Skills, & Abilities • Working knowledge of clinical research, Good Clinical Practices (GcP), and regulatory requirements/guidelines. • Proficient in SAS; familiar with sample size software such as nQuery or PASS. • Experience as a Lead Biostatistician on several concurrent projects. • CDISC STDM/ADaM experience. • Excellent English verbal and written communication skills; good organizational and interpersonal skills.

Working Environment / Physical Environment • This position work onsite  or remotely depending on the candidate’s geographic location. • Regular work schedule is Monday – Friday, within standard business hours.  Flexibility is available with manager approval. • Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer. • Lift and carry materials weighing up to 20 pounds.

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

National Market (all markets unless identified as Premium) $144,000 (entry-level qualifications) to $160,000 (highly experienced) annually

Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston) $162,000 (entry-level qualifications) to $180,000 (highly experienced) annually

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.   Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring de

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