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Associate Director, Standards Developer

8+ years
Not Disclosed
10 Jan. 22, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Director, Standards Developer
Job ID: R-210138
Date Posted: 01/20/2025
Career Level: E
Employer: AstraZeneca


Introduction to the Role:

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.


Key Responsibilities:

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.


Essential Skills & Experience:

  • Educational Requirements:

    • BSc in Information Sciences, Mathematical, Statistical, Computer Science, Life Science, or equivalent experience.
  • Technical Expertise:

    • Expertise in specialized analysis and reporting standards development, with a primary focus on ADaM standards.
    • In-depth knowledge of industry standards such as CDASH, SDTM, and ADaM.
  • Communication Skills:

    • Excellent communication skills in both written and spoken English.
  • Project Management:

    • Strong project management skills and experience managing complex tasks.
  • Leadership & Mentorship:

    • Ability to mentor, train, and lead teams effectively.
  • Clinical Development Process Knowledge:

    • A thorough understanding of the clinical development process.
  • Agility & Responsiveness:

    • Ability to respond quickly and effectively to industry and business needs.

Desirable Skills & Experience:

  • Programming Languages:

    • Knowledge of programming languages other than SAS (e.g., R, Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, Python, Pearl).
  • Stakeholder Management:

    • Ability to influence stakeholders on standards-related topics.
  • Risk Management:

    • Ability to assess and manage risks effectively.
  • Line Management:

    • Ability to manage teams and individuals.

Work Environment:

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.


Why Join AstraZeneca?

  • 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.


How to Apply:

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.


Equal Opportunity:

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