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Standards and Automation Lead - Oncology

Plats Gaithersburg, Maryland, USA Jobb-id R-088142 Datum inlagd 08/05/2020

Would you like to be a part of a Programming group that has direct strategic impact on drug development, playing a key role in getting medicines to patients?

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

The new R&D Oncology organisation brings together early and late oncology teams, from discovery through to late-stage development, with oncology specific Regulatory and Biometrics groups.

Ultimately, the Oncology Programming department oversees and delivers all of the programming contribution to internal decision making, regulatory submissions and reporting and commercial activities for the portfolio of drug projects within the Oncology R&D organisation. 

If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.

Role

You will provide  clinical data standards and tool support for the analysis and reporting process including, but not limited to, Clinical Study Report development, regulatory submissions, commercialisation and the scientific utilisation of our data for AstraZeneca products.  There are many career options you can pursue for progression including technical pathways, management of global projects or line management.

You’ll be part of a global team that pulls together to put patients first.

Responsibilities

Reporting to an Associate Director/Director within the Oncology Programming group you will provide clinical data standards leadership and tool support in one or more of the following areas:

In close collaboration with the Associate Director of Standards and Automation and their Therapeutic Area Programming Director:

  • At study start up, join the project teams within their TA to review Protocols and direct the proper and consistent use of corporate and TA end-to-end standards. 
  • May participate on the Therapeutic Area Standards Development Team and contribute to the review and optimization of corporate and Therapeutic Area (TA) standards.
  • Verify/enforce that standard programming tools and automation are used in reporting or validation programming, i.e., SDTM mapping, ADaM macros/automation and derivations, and analysis and reporting tools.
  • In close collaboration with Biometrics Automation & Tools group, contribute to the development of corporate and TA tools and automation.
  • In consultation with the Business Process Team and the EntimICE subject matter experts, review and set the A&R system properties so that performance is optimized.
  • Consult with TA programming teams facilitating the creation of the Quality and Validation Plans.

Requirements

To succeed in this role, you’ll be an enthusiastic individual with an understanding of technical and regulatory requirements related to programming within the pharmaceutical or healthcare industry. You’ll enjoy multitasking, collaborating as part of a global team, and have an appetite for solving problems.  You will be an effective communicator, with a strong team focus who enjoys collaborating to achieve the best results.

Desirable experience includes:

  • BSc in a Mathematical (i.e. Applied Math, Engineering, etc.), Statistical, Computer Science or Life Science subject
  • Excellent problem-solving skills
  • Diligence – attention to detail and ability to manage concurrent projects and activities
  • Excellent verbal and written communication skills and ability to influence stakeholders

TA Standards and Automation Leader

  • Extensive SAS programming expertise to an advanced level gained within a clinical drug development or healthcare environment
  • Comprehensive knowledge of technical and regulatory requirements with submission experience
  • Wide-ranging knowledge of CDISC standards and industry best practices
  • Travel – willingness and ability to travel domestically and/or internationally
  • Team centric approach: keen to take steps to understand and appreciate the roles, skills and strengths of others on the team

We would like to know more about you. If you are interested, apply now!

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

Where can I find out more?



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 authorisation and employment eligibility verification requirements.

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