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:
- Ensure SEND-compliant datasets for nonclinical studies.
- Maintain metadata libraries and enforce nonclinical data standards.
- Review and implement updated CDISC SEND standards.
- Collaborate with external vendors to ensure data compliance.
- Perform quality validation of nonclinical datasets.
- Support data warehousing, visualization, and submission readiness.
- Train internal teams on SEND standards and best practices.
- Work with LIMS (Laboratory Information Management Systems) and SEND solution software.
Qualifications & Experience Required
Essential Skills:
- Bachelor’s degree (B.A./B.S.) in Life Sciences, Biotechnology, Pharmacy, or related fields.
- 0-3 years of experience in a scientific or regulatory data environment.
- Knowledge of CDISC SEND standards and nonclinical study data.
- Understanding of FDA, ICH, GLP, and PhUSE guidelines.
- Experience with data processing, LIMS, and SEND tools.
- Strong communication skills (written & spoken English).
Desirable Skills:
- Experience in pharma/biotech regulatory submissions.
Why Join AstraZeneca?
- Innovative Work Culture:Â Collaborate with experts in drug development and regulatory science.
- Hybrid Work Model: Minimum 3 days/week in-office with flexibility.
- Career Growth:Â Continuous learning and development opportunities.
- Global Impact:Â Contribute to life-changing medicines for patients worldwide.