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    Senior Standards Developer I

    Astrazeneca
    2+ years
    Not Disclosed
    India
    10 Oct. 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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: Senior Standards Developer I
    Career Level: D
    Location: AstraZeneca Biopharmaceuticals R&D

    Introduction to the Role

    Join our Biopharmaceuticals R&D team as a Senior Standards Developer I. In this role, you will be responsible for delivering moderate complexity AZ end-to-end Clinical Analysis and Reporting Standards within your area of expertise. Your technical skills and industry knowledge will empower you to independently perform tasks while knowing when to seek guidance in complex situations. You will primarily focus on developing and creating study metadata for SDTM and ADaM in a specific system.

    Accountabilities

    As a Senior Standards Developer I, you will:

    • Develop and maintain one or more median/high complexity analysis and reporting standards.
    • Monitor and update requests within a defined system, ensuring quality control and leading the quality of your deliverables.
    • Contribute to the development of best practices for consistently developing, maintaining, and publishing data standards.
    • Collaborate with clinical standards governance groups and serve as a subject matter expert in support of AZ Clinical Standards for drug projects.
    • Assist with metric reporting on standards and requests, and contribute to the function by training and mentoring team members.

    Essential Skills and Experience

    • Bachelor’s degree in Information Sciences, Mathematics, Statistics, Computer Science, Life Sciences, or equivalent experience.
    • Proficiency in specialized standards development skills or experience within Biometrics functions.
    • Strong knowledge of MS Excel, with deep attention to detail and a systematic approach to work.
    • Familiarity with the clinical development process.
    • Solid project management skills.
    • Good understanding of industry standards (e.g., CDASH, SDTM, ADaM).
    • Knowledge of clinical dictionaries, including MedDRA, WHODrug Global, and Labcodes.
    • Familiarity with medical terminology and pharmacology as it relates to pharmaceutical drug development and associated regulations.
    • Effective communication skills in both written and spoken English.
    • A commitment to truth-seeking behaviors and embracing peer review.

    Desirable Skills

    • Ability to apply clinical data standards technical knowledge to problem-solving.
    • Proactive management of concurrent activities.
    • Understanding of programming languages (e.g., SAS, R, Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, Python, Perl).
    • Clinical laboratory experience.

    Our Working Environment

    At AstraZeneca, we believe that unexpected teams inspire bold thinking, leading to life-changing medicines. Our in-person work model averages three days per week in the office, fostering collaboration while respecting individual flexibility.

    About AstraZeneca

    At AstraZeneca, we follow the science unlike anywhere else. We are committed to understanding and revealing new insights, free from the fear of failure. By listening to those affected by the diseases we treat, we can better understand their needs and develop impactful treatments. We are harnessing digital, data science, and AI to achieve the next wave of breakthroughs.

    Join Us

    Are you ready to join a team making a difference? Are you ready to follow the science? Apply now!

    AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds. We welcome applications from all qualified candidates and comply with all laws and regulations regarding non-discrimination in employment.

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