Position SummaryThe 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.
