Specialist III, Biometrics
ImmunityBio, Inc.
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.
Job description
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.
Requirements
- Bachelor’s Degree in Statistics, Biostatistics or related scientific discipline with 5+ years relevant statistical experience in the Biotech or Pharmaceutical industry; or Master’s Degree with 3+ years; or Doctorate degree with 1+ year
- Experience in the preparation of the submission of clinical and nonclinical modules in eCTD format
- 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
Benefits
- Medical, Dental & Vision
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Life/AD&D Insurance
- Short-Term Disability
- Long-Term Disability
- Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary Legal Services
- Identity Theft Protection
- Pet Insurance
- Employee Discounts
- Paid Time Off
- 11 Holidays
- Unlimited PTO for Exempt Employees
Company overview
ImmunityBio, Inc. is a clinical-stage biotechnology company headquartered in San Diego, California, that specializes in developing innovative cell and immunotherapy products for the treatment of advanced cancers and infectious diseases. Founded in 2014 by Dr. Patrick Soon-Shiong, the inventor of the world's first protein nanoparticle drug Abraxane, the company focuses on creating therapies that strengthen patients' natural immune systems to combat diseases. ImmunityBio's pipeline includes promising candidates like ANKTIVA for various cancer indications, with a particular emphasis on bladder cancer, lung cancer, and other solid tumors. The company employs approximately 500-1,000 professionals and operates internationally with facilities across the United States. ImmunityBio's approach centers on activating both branches of the immune system to attack diseased cells while building immunological memory for long-term protection. The company is publicly traded on NASDAQ under the ticker symbol IBRX and continues to advance its clinical programs through strategic collaborations and ongoing research initiatives.