Senior Standards Developer I

2 weeks ago

Bengaluru, India AstraZeneca Full time

Introduction to role:

Join our Biopharmaceuticals R&D team as a Senior Standards Developer I, where you will be responsible for delivering moderate complexity AZ end-to-end Clinical Analysis and Reporting Standards in your area of expertise. This role requires technical skills and adequate industry knowledge to independently perform tasks while using judgement about seeking guidance in complex situations. You will be primarily responsible for the development and creation of 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. You will monitor and update requests within a defined system, perform independent quality control, and lead the quality of your own deliverables. You will also contribute to the development of best practices to develop, maintain and publish data standards consistently. Collaboration with clinical standards governance groups is key, as is contributing as a subject matter expert support to drug projects on AZ Clinical Standards. You will also assist with metric reporting on standards and requests, and contribute to the function by training and mentoring.


Essential Skills/Experience:

- BSc in Information Sciences, Mathematical, Statistical, Computer Science or Life Science or equivalent experience.

- Accomplished in specialised standards development skills or accomplished experience in Biometrics functions.

- Knowledge of MS Excel, deep attention to the details and a systematic approach to work.

- Good knowledge of the clinical development process.

- Good Project management skills.

- Good knowledge of industry standards (eg, CDASH, SDTM, ADaM).

- Good knowledge of the structure and application of clinical dictionaries including MedDRA, WHODrug Global, and Labcodes.

- Good knowledge of medical terminology and pharmacology as it relates to pharmaceutical drug development and associated regulations.

- Good communication skills in both written and spoken English.

- A clear demonstration of behaviours of truth seeking rather than success seeking.

- Embracing peer review.


Desirable

- Ability to apply clinical data standards technical knowledge to problem solving.

- Ability to proactively manage concurrent activities within role.

- Understanding of programming languages (eg, SAS, R, Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, Python, Pearl).

- Clinical Laboratory experience.

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