Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

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