Specialist III, Biometrics

nant; Summit (NJ); On-site; USD 120,000 - 160,000; Full time

Job summary

ImmunityBio is seeking a Specialist III, Biometrics to help develop global clinical regulatory methods and assist with eCTD submissions. The role requires SAS and CDISC proficiency, data management, and collaboration with regulatory teams to ensure compliant documentation for INDs, CTAs, and BLAs.

The position is on-site in Summit, NJ, with responsibilities including data queries, listings, and preparation of CDISC datasets and support materials for FDA submissions.

Qualifications

• Bachelor’s degree in Statistics, Biostatistics or related field with 5+ years of statistical experience in biotech/pharma.
• Master’s degree with 3+ years of experience in biotech/pharma.
• Doctorate with 1+ year of experience in biotech/pharma (preferred).

Responsibilities

• Assist in development of global clinical regulatory methods for investigational and marketed products.
• Review tables/listings/figures of clinical studies.
• Support preparation of non-clinical and clinical reports and CDISC datasets.

Skills

SAS programming

CDISC standards

Regulatory submissions

Attention to detail

Education

Bachelor's degree in Statistics/Biostatistics or related field

Master's degree in Statistics/Biostatistics or related field

Doctorate in Statistics/Biostatistics or related field

Tools

SAS Software

eCTD preparation

Job description

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 ba