Senior Statistical Programmer at AstraZeneca
Job ID: R-202817
Date Posted: 08/08/2024
Career Level: D
Location: Bangalore, India
Introduction to Role
Join AstraZeneca as a Senior Statistical Programmer within our Respiratory and Immunology group. Play a critical role in making our pipeline accessible to patients by leveraging your expertise in SAS Programming. If you're passionate about drug development and regulatory interactions, this opportunity is for you!
About AstraZeneca
AstraZeneca is a global biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines for serious diseases. Our team is dedicated to treating, preventing, and modifying complex conditions, positively impacting the lives of billions worldwide.
Main Duties and Responsibilities
In this role, you will utilize your statistical programming skills to analyze and report on clinical trials and exploratory analyses, supporting our product portfolio.
Key Responsibilities
Lead Regulatory Submissions: Manage statistical programming deliverables, including datasets, outputs, and responses to regulatory queries.
Clinical Study Reports: Oversee deliverables for Clinical Study Reports (CSR), SDTM/ADaM databases, and TFL outputs, adhering to data standards and regulations.
Safety Reports: Lead programming efforts for Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), and Investigators' brochures (IB).
Collaborative Analysis: Contribute to statistical programming thinking and reporting within product and study teams.
Methodology Development: Enhance quality and efficiency through the development of standard methodologies.
Project Management: Apply good practices in estimation, risk management, and status tracking when planning and leading deliverables.
CRO Oversight: Ensure high-quality standards of deliverables from CROs and partners.
Essential Requirements
Education: Degree in Mathematics, Computer Science, Statistics, Life Sciences, or a related field.
Experience: Strong background in clinical drug development or healthcare.
Technical Skills: Advanced SAS programming and knowledge of CDISC standards and industry best practices.
Interpersonal Skills: Excellent communication and teamwork abilities.
Desirable Qualifications
Therapeutic Experience: Familiarity with Respiratory or Immunology areas.
Programming Languages: Experience with other languages such as S-PLUS, R, Python, or XML.
Validation Tools: Knowledge of Pinnacle 21 Validator.
Why AstraZeneca?
At AstraZeneca, we empower our employees to innovate and push the boundaries of science. We foster an inclusive culture that champions diversity and supports lifelong learning and development. Join us on our journey to pioneer the future of healthcare.
Ready to Make an Impact?
If you're ready to contribute new ideas and thinking, we want to hear from you!
Explore More About Us:
AstraZeneca is committed to diversity and equality of opportunity. We welcome applications from all qualified candidates and comply with all applicable laws and regulations on non-discrimination in employment.
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