Senior Biometrics Specialist - Regulatory Submissions & SAS

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

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.