Statistical Programmer, Associate Director (Data Standards & Automation) – Late R&I

Location: Cambridge, UK, Gaithersburg, US or Gothenburg, Sweden

Competitive salary and benefits

Play a critical role in making our pipeline accessible to patients.

Do you have expertise in, and passion for, SAS Programming? Would you like to apply your skills to impact all phases of drug development and regulatory interactions, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world’s most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world.

We work on some of the most complex and interesting challenges. A fast-paced and agile team, we are empowered and trusted to innovate and experiment. With access to our extensive capabilities and comprehensive pipeline, you’ll be involved in countless submissions and a wide range of engaging projects along the complete drug development process.

Our Late R&I Biometrics team is dedicated to the development of innovative treatment of Respiratory and Immunology (R&I) diseases. You will join a global, diverse and cross-functional environment where you will get personal and professional development.

In this role, we will give you the chance to utilise your statistical programming expertise in analysis and reporting of clinical trial programs; submission and defence of regulatory filings and the generation of evidence to support product commercialisation and reimbursement.

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, you will provide clinical data standards leadership and tool support in one or more of the following areas:

• 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

Why AstraZeneca?

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Where can I find out more?

• Our Social Media, Follow AstraZeneca on LinkedIhttps://www.linkedin.com/company/1603/
• Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
• Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Date advert opened: 9th September 2021

Date advert closed for applications: 9th October 2021

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.