Specialist III, Biometrics
ImmunityBio, Inc.•Dunkirk, NY
•$130,000 - $143,000•Onsite
About The Position
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.
Requirements
- 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.
- 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
Responsibilities
- 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.
Benefits
- Medical, Dental and Vision Plan Options
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
- Healthcare and Dependent Care Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
- Paid Time Off (PTO) includes: 11 Holidays
- Exempt Employees are eligible for Unlimited PTO
- Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
