ImmunityBio

ImmunityBio

Specialist III, Biometrics

Summit, NJ · Mid

Sponsorship not specifiedDetected 1 day ago
StatisticsFDA RegulatorySASResearchCommunicationOrganizational SkillsBiostatisticsRegulatory Affairs

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Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Files H-1B transfers

1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

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About the role

  • 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.
  • In addition, this position will review the tables, listings, and figures of clinical studies.
  • 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.

Responsibilities

  • Partner with regulatory affairs team to complete marketing applications.
  • Perform ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
  • Support the preparation of non-clinical and clinical reports and summaries through database queries and preparation of ad hoc listings and tables
  • This desk-based role involves the close study of scientific and regulatory documents

Requirements

  • 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.
  • Bachelor's Degree in Statistics, Biostatistics or related scientific discipline with 5+ years relevant statistical experience in the Biotech or Pharmaceutical industry required
  • Master's Degree in Statistics, Biostatistics or related scientific discipline with 3+ years relevant statistical experience in the Biotech or Pharmaceutical industry required
  • 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.
  • 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
  • Bachelor's Degree in Statistics, Biostatistics or related scientific discipline with 5+ years relevant statistical experience in the Biotech or Pharmaceutical industry required; or

Skills

  • Knowledge, Skills, & Abilities
  • Excellent organizational skills, written and oral communication skills, and attention to detail

Compensation

  • The annual base pay range for this position is below.

Benefits

  • Catalogue and evaluate datasets and documentation with respect to Health Authority regulations and guidance documents
  • Health and Financial Wellness Programs
  • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability

Company info

  • We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.
  • At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace.

Visa & Work Authorization

  • race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law
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This listing is sourced directly from ImmunityBio's careers page and normalized into a canonical job model.