Specialist III, Biometrics

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 Specialist III, Biometrics will assist in the development of global clinical regulatory methods for investigational and marketed products and will assist with the preparation of dossiers in eCTD format.  The Specialist III, Biometrics will use Statistical Analysis System (SAS) in the management of clinical trial datasets, data integration, clinical and nonclinical CDISC datasets, and required documentation. In addition, this position will review the tables, listings, and figures of clinical studies. Essential Functions Partner with regulatory affairs team to complete marketing applications. Ensure the maintenance of ongoing trials, INDs, CTAs, BLAs, etc., through the review and submissions of IBs, DSURs, BLA PAERs, investigator documentation and health authority commitments. Ensure that submission datasets meet the current FDA Data Standards Requirements for IND, NDA, and BLA submissions to CDER/CBER Ensure that the current FDA Study Data Technical Conformance Guidelines are followed for SEND, SDTM and ADaM. Catalogue and evaluate datasets and documentation with respect to Health Authority regulations and guidance documents Support the preparation of non-clinical and clinical reports and summaries through database queries and preparation of ad hoc listings and tables Review or prepare CDISC datasets and documentation for FDA submission including, but not limited to, reviewers guides, define.xml, etc. Provide quality control of CDISC files during the eCTD publishing process on the XML backbone. Perform ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience Bachelor’s Degree in Statistics, Biostatistics or related scientific discipline with 5+ years relevant statistical experience in the Biotech or Pharmaceutical industry required; or Master’s Degree in Statistics, Biostatistics or related scientific discipline with 3+ years relevant statistical experience in the Biotech or Pharmaceutical industry required; or Doctorate degree in Statistics, Biostatistics or related scientific discipline with 1+ year relevant statistical experience in the Biotech or Pharmaceutical industry required. Experience in the preparation of the submission of clinical and nonclinical modules in eCTD format required. Knowledge, Skills, & Abilities Strong knowledge of SAS programming and CDISC. Knowledge of FDA standardized study data guidance and requirements for regulatory electronic submissions Knowledge of FDA therapeutic area standard initiatives and FDA supported CDISC standards Working knowledge of clinical and nonclinical research and related regulatory requirements/guidelines Excellent organizational skills, written and oral communication skills, and attention to detail Working Environment / Physical Environment This position works on site in Summit, NJ. as noted in the offer letter. Regular work schedule is Monday – Friday, within standard business hours.  Flexibility is available with manager approval. This position may need to sit for long periods of time and use various computer programs This desk-based role involves the close study of scientific and regulatory documents This position will work closely with scientific colleagues throughout the day, often on a project-team basis 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. $130,000 (entry-level qualifications) to $143,000 (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. Hi