Specialist III, Biometrics

Role: The Specialist III, Biometrics supports global clinical regulatory processes, focusing on statistical data management and submission preparation for investigational and marketed biopharmaceutical products. Responsibilities include ensuring datasets meet FDA standards, managing clinical trial data using SAS and CDISC, preparing regulatory documentation, and supporting the compilation of eCTD dossiers for submissions like INDs, NDAs, and BLAs. Requirements: Bachelor’s (5+ years), Master’s (3+ years), or Doctorate (1+ year) in Statistics, Biostatistics, or related field; extensive SAS and CDISC experience; familiarity with FDA data standards and regulatory guidelines. Preferred: Experience with clinical and nonclinical submission datasets, knowledge of regulatory guidelines for inclusive and compliant data submissions. High-Value: Focus on immunotherapy, cell therapy, or oncology products; involvement in regulatory document preparation for global submissions; on-site role in Summit, NJ; requires attention to detail and strong organizational skills.