Senior Standards Developer I

5+ years

Not Disclosed

Remote

10 Oct. 24, 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 ID: R-195386
Date Posted: July 10, 2024
Career Level: D

Role Overview

Join our Biopharmaceuticals R&D team as a Senior Standards Developer I. In this role, you will be responsible for delivering moderate complexity Clinical Analysis and Reporting Standards at AstraZeneca. Your technical skills and industry knowledge will empower you to perform tasks independently, while also exercising judgment in complex situations. You will primarily focus on developing and creating study metadata for SDTM and ADaM within a specific system.

Key Responsibilities

Standards Development: Develop and maintain one or more medium to high complexity analysis and reporting standards.
Quality Control: Monitor and update requests within a defined system, perform independent quality control, and ensure high quality in your deliverables.
Best Practices Contribution: Collaborate with clinical standards governance groups to establish and maintain best practices for developing and publishing data standards.
Subject Matter Expertise: Provide expert support to drug projects on AZ Clinical Standards, including assisting with metric reporting on standards and requests.
Training and Mentorship: Contribute to team development by training and mentoring peers.

Essential Skills and Experience

Education: BSc in Information Sciences, Mathematics, Statistics, Computer Science, Life Sciences, or equivalent experience.
Standards Development: Proficiency in specialized standards development or significant experience in Biometrics functions.
Technical Proficiency: Knowledge of MS Excel, a keen attention to detail, and a systematic approach to work.
Clinical Knowledge: Familiarity with the clinical development process and industry standards (e.g., CDASH, SDTM, ADaM).
Regulatory Understanding: Knowledge of clinical dictionaries like MedDRA, WHODrug Global, and Labcodes, along with medical terminology and pharmacology.
Communication Skills: Strong written and verbal communication skills in English.
Integrity and Collaboration: Demonstrated behaviors of truth-seeking and an embrace of peer review.

Desirable Skills and Experience

Problem-Solving Skills: Ability to apply technical knowledge of clinical data standards to address challenges.
Project Management: Capability to proactively manage concurrent activities within the role.
Programming Knowledge: Understanding of programming languages such as SAS, R, Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, Python, or Perl.
Clinical Laboratory Experience: Experience in clinical laboratory settings is a plus.

Work Environment

At AstraZeneca, we believe in the power of collaboration. We work a minimum of three days a week from the office, balancing in-person connection with individual flexibility.

Commitment to Diversity

AstraZeneca is dedicated to fostering an inclusive and diverse team that represents all backgrounds and perspectives. We encourage applications from all qualified candidates and comply with all applicable laws regarding non-discrimination in employment.

Are you ready to make a difference? Apply now and join our mission to follow the science!

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Senior Standards Developer I

Job Description

Role Overview

Key Responsibilities

Essential Skills and Experience

Desirable Skills and Experience

Work Environment

Commitment to Diversity

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