Standards Developer I

Job Title: Standards Developer I

Career Level - C

Introduction to role

The Standards Developer I is primarily responsible for providing support to deliver lower complexity AZ end-to-end Clinical Analysis & Reporting Standards in their area of expertise (e.g. clinical dictionaries, and data analysis & reporting standards (SDTM, ADaM, TLFs)) with quality and timeliness, following established standards and processes. You will liaise with various departments on a local level to ensure the delivery of analysis and reporting standards. You may work under the direction of a Senior or Associate Director Standards Developer.

Accountabilities

• Under supervision, develop and maintain lower complexity analysis and reporting clinical standards (e.g. clinical dictionaries, and data analysis & reporting standards (SDTM, ADaM, TLFs))

• Monitor, develop, and update requests within defined systems

• Lead the quality of own deliverables and ensure completeness of applicable quality and process documentation

• Collaborate with other Standards Developers

• Seek to acquire knowledge of data management standards development processes

• Take steps to understand the roles and skills of others in clinical data standards

• Take steps to understand the roles and skills of other functions in drug development

Essential Skills/Experience

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

• Knowledge of MS Excel, deep attention to details and systematic approach to work

• Good communication skills in both written and spoken English

Desirable Skills/Experience

• Knowledge of the existence of industry standards (e.g., CDASH, SDTM, ADaM)

• Experience with clinical data standards (e.g., in Programming, Statistics)

• Ability to understand and adhere to business processes

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

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. Our pioneering spirit drives us to make bold moves that transform cancer treatment and improve patient outcomes. With one of the broadest and deepest Oncology pipelines in the industry, you will have many opportunities to work with new and novel

drugs. We foster a mindset of courage where everyone is empowered to innovate and work at pace. Join us in our mission to make a meaningful difference for patients around the world.

Ready to make a difference? Apply now!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.