Job Title: Associate Director, Standards Developer
Job ID: R-210138
Date Posted: 01/20/2025
Career Level: E
Employer: AstraZeneca
As an Associate Director, Standards Developer at AstraZeneca, you will lead the technical development, management, and maintenance of end-to-end Clinical Analysis & Reporting Standards (CARS) activities. You will serve as the subject matter expert in clinical coding, clinical dictionaries, and data analysis & reporting standards, primarily focusing on ADaM standards, but also SDTM and TLFs. This role requires a high level of technical expertise and in-depth industry knowledge to manage and perform standards tasks. Additionally, you will have the opportunity to lead cross-functional projects, manage external partner relationships, and provide coaching to junior colleagues.
As the Associate Director, Standards Developer, your responsibilities will include:
Lead Clinical Standards Development:
Manage end-to-end clinical data standards and act as a technical subject matter expert in specialized areas of analysis and reporting standards.
Partner & Vendor Management:
Oversee the quality of deliverables from CROs and external partners, ensuring alignment with the standards set by the business.
Standards Development & Implementation:
Drive the development and implementation of analysis and reporting standards within AstraZeneca.
Team Management & Mentorship:
Mentor, train, and lead teams in the development and implementation of clinical standards. Contribute to recruitment, training, and process improvement initiatives.
Cross-functional Collaboration:
Lead and contribute to cross-functional projects and initiatives that relate to analysis and reporting standards.
Educational Requirements:
Technical Expertise:
Communication Skills:
Project Management:
Leadership & Mentorship:
Clinical Development Process Knowledge:
Agility & Responsiveness:
Programming Languages:
Stakeholder Management:
Risk Management:
Line Management:
At AstraZeneca, we believe that working in-person fosters collaboration, bold thinking, and innovation. While the expectation is to work a minimum of three days per week in the office, we respect individual flexibility to ensure a balanced work-life environment.
Growth & Development:
AstraZeneca provides opportunities for professional development and growth in a dynamic, innovative environment.
Diversity & Inclusion:
We are committed to building an inclusive team that represents a wide range of perspectives. We believe that diversity is our strength and fosters better decision-making and innovation.
Impact:
Join us and contribute to groundbreaking work that inspires life-changing medicines.
If you are ready to take on a leadership role in clinical standards development, apply now to join AstraZeneca’s dynamic team and help shape the future of clinical development.
AstraZeneca is committed to diversity and equal opportunity. We encourage all qualified candidates to apply, regardless of their background or characteristics. We comply with all applicable laws on non-discrimination and work authorization and employment eligibility verification requirements
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
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Rangpo |Tamil Nadu :
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