Specialist III, Biometrics

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. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day •  We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.