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Associate Director, Standards Developer

2+ years
Not Disclosed
10 Feb. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc 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

Lead the Future of Clinical Data Standards

Are you ready to take charge of the technical development, management, and maintenance of end-to-end Clinical Analysis & Reporting Standards? As an Associate Director, Standards Developer, you will be the subject matter expert in key areas such as clinical coding, clinical dictionaries, and data analysis & reporting standards—with a primary focus on ADaM standards and additional expertise in SDTMs and TLFs.

This role demands high technical proficiency and deep industry knowledge to lead and execute standards tasks, drive cross-functional initiatives, manage external partnerships, and mentor junior colleagues.

Key Responsibilities:

  • Lead end-to-end clinical data standards development at AstraZeneca.
  • Act as a technical subject matter expert in specialized areas of clinical analysis and reporting standards.
  • Oversee CRO and external partner activities, ensuring the quality of standards deliverables.
  • Drive development and implementation of standards within the business.
  • Lead cross-functional projects and initiatives related to analysis and reporting standards.
  • Provide mentorship, training, and leadership to junior team members.
  • Contribute to functional recruiting, training, and process improvement initiatives.

Required Qualifications & Experience:

  • BSc in Information Sciences, Mathematics, Statistics, Computer Science, or Life Sciences, or equivalent experience.
  • Expertise in clinical analysis and reporting standards development.
  • Strong knowledge of industry standards (CDASH, SDTM, ADaM) with a primary focus on ADaM.
  • Excellent verbal and written communication skills in English.
  • Strong project management capabilities.
  • Proven ability to mentor, train, and lead teams.
  • Deep understanding of the clinical development process.
  • Agile approach to industry and business needs.

Preferred Qualifications:

  • Experience with programming languages beyond SAS (e.g., R, Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, Python, Perl).
  • Ability to influence stakeholders on standards-related decisions.
  • Strong risk management skills.
  • Ability to manage direct reports.

Our Work Culture

At AstraZeneca, we thrive on collaboration, innovation, and bold thinking. By bringing together diverse teams in-person, we accelerate progress and push the boundaries of science. Our approach blends on-site teamwork (minimum three days a week) with flexibility, ensuring a balance that fuels productivity and innovation.

Why Join Us?

We are committed to diversity, inclusion, and equal opportunity—believing that a team with varied perspectives drives better results. If you’re ready to shape the future of clinical data standards, apply now and be part of a company that transforms patient lives!