Senior Biostatistician

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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 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 appli