AstraZeneca is a global biopharmaceutical company committed to transforming the lives of patients through innovative science. With a strong focus on oncology, cardiovascular, renal & metabolic diseases, and respiratory & immunology, we push the boundaries of medical research. Our inclusive culture fosters curiosity, collaboration, and lifelong learning, making AstraZeneca a great place to grow your career.
Job Description
AstraZeneca is seeking a Nonclinical SEND Data Associate to support the standardization and management of nonclinical study data in compliance with CDISC SEND (Standard for Exchange of Nonclinical Data) standards. This role is critical in ensuring regulatory submissions meet FDA, ICH, and GLP requirements while enabling data-driven decision-making.
Key Responsibilities:
- EnsureΒ SEND-compliant datasetsΒ for nonclinical studies.
- MaintainΒ metadata librariesΒ and enforceΒ nonclinical data standards.
- Review and implementΒ updated CDISC SEND standards.
- Collaborate withΒ external vendorsΒ to ensure data compliance.
- PerformΒ quality validationΒ of nonclinical datasets.
- SupportΒ data warehousing, visualization, and submission readiness.
- Train internal teams onΒ SEND standards and best practices.
- Work withΒ LIMS (Laboratory Information Management Systems)Β andΒ SEND solution software.
Qualifications & Experience Required
Essential Skills:
- Bachelorβs degree (B.A./B.S.)Β in Life Sciences, Biotechnology, Pharmacy, or related fields.
- 0-3 years of experienceΒ in a scientific or regulatory data environment.
- Knowledge of CDISC SEND standardsΒ and nonclinical study data.
- Understanding ofΒ FDA, ICH, GLP, and PhUSEΒ guidelines.
- Experience withΒ data processing, LIMS, and SEND tools.
- StrongΒ communication skillsΒ (written & spoken English).
Desirable Skills:
- Experience inΒ pharma/biotech regulatory submissions.
Why Join AstraZeneca?
- Innovative Work Culture:Β Collaborate with experts in drug development and regulatory science.
- Hybrid Work Model:Β MinimumΒ 3 days/week in-officeΒ with flexibility.
- Career Growth:Β Continuous learning and development opportunities.
- Global Impact:Β Contribute to life-changing medicines for patients worldwide.
