Senior Standards Developer Ii – Rave Subject Matter Expert

5+ years

Not Disclosed

Bengaluru

10 Dec. 27, 2024

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: Senior Standards Developer II – RAVE Subject Matter Expert
Job ID: R-215188
Date Posted: 12/16/2024
Career Level: D

Introduction to the Role:
Are you ready to make a significant impact in the field of clinical data standards? As a Senior Standards Developer II – RAVE Subject Matter Expert, you will lead the development, management, and maintenance of complex data collection and cleaning components within the RAVE Global Library of Clinical Data Standards. Your expertise will help ensure adherence to industry and company standards, providing technical solutions for data collection and cleaning. This role requires a high level of technical proficiency and deep industry knowledge, enabling you to independently handle standards tasks while providing sound judgment in complex situations. You will also lead RAVE component deliverables and serve as the key point of contact for cross-functional projects.

Key Responsibilities:

Develop, manage, and maintain high-complexity data collection and cleaning components in the RAVE Global Library.
Monitor and update requests, advising on possible impacts and implementations.
Perform independent quality control and ensure the quality of your deliverables, overseeing other developers' work.
Contribute to the development of best practices for creating, maintaining, and publishing data standards consistently.
Collaborate with Clinical Standards governance groups.
Provide expert support for drug projects on AZ Clinical Standards, leveraging your technical expertise.
Assist with metric reporting on standards and requests.
Manage activities of external partners.
Serve as a technical subject matter expert in RAVE components and specialized clinical standards.
Contribute to recruitment, training, and mentoring within the function.

Essential Skills & Experience:

BSc in Information Sciences, Mathematical, Statistical, Computer Science, Life Science, or equivalent experience.
5+ years of experience in RAVE, including custom function programming.
Medidata study build certificate (SDBE) required.
Knowledge and experience in optimizing form designs, field attributes, log forms, dynamics, edit checks, custom functions, and derivations.
Experience in validation processes.
Good knowledge of RAVE Safety Gateway (added advantage).
Advanced CSharp programming skills (preferred).
Strong knowledge of MS Excel, attention to detail, and a systematic work approach.
Good understanding of the clinical development process.
Project management experience.
Excellent communication skills (both written and spoken English).
Demonstrated truth-seeking behavior and acceptance of peer review.

Desirable Skills & Experience:

Ability to apply technical knowledge to problem-solving.
Experience managing concurrent activities.
Familiarity with other programming languages (e.g., SAS, R, Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, Python, Perl).
Knowledge of industry standards (e.g., CDISC-CDASH/SDTM).

Work Culture:
At AstraZeneca, we believe in unleashing ambitious thinking through collaboration. By working in-person for at least three days per week, we foster an environment that connects teams, accelerates progress, and challenges norms. While we expect time in the office, we also respect individual flexibility.

Our Mission:
We are dedicated to changing the practice of medicine and transforming the lives of patients living with cancer. Through innovative approaches like novel biomarkers, AI, and groundbreaking trial designs, we are developing life-changing medicines. Our collaborative environment empowers team members to take smart risks, challenge perceptions, and learn from failures. Join us in our mission to eliminate cancer as a cause of death.

Ready to make a difference?
Apply now and become part of our unique and ambitious world at AstraZeneca!

Diversity & Inclusion:
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds. We believe that inclusivity drives better results in our work. We welcome applications from all qualified candidates, regardless of characteristics, and comply with all applicable laws and regulations regarding non-discrimination, work authorization, and employment eligibility verification.

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Senior Standards Developer Ii – Rave Subject Matter Expert

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