Senior Statistical Programmer II
AstraZeneca

Gaithersburg, Maryland

Posted in Pharmaceuticals


Job Info


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

Do you have expertise in, and passion for, 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, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization 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.

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.

The Role

You will provide Statistical Programming support and/or lead all programming related activities of the analysis and reporting process including, but not limited to, CSR development, regulatory submissions, commercialization and the scientific utilization 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 will work in the Programming department that not only oversees and delivers the programming aspects of analysis and reporting but also manages and maintains our end to end standards and our analysis and reporting production tools.

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

Main Duties and Responsibilities

Reporting to the Director within the Statistical Programming group you will provide programming expertise in one or more of the following areas:

  • Lead/Contribute to the delivery of the Clinical Study Report (CSR), Study Data Tabulation Model (SDTM)/Analysis Data Model (ADaM) databases and Tables, Figures and Listings (TFL) outputs through both internal and external delivery models
  • Lead/Contribute to the statistical programming deliverables for regulatory submissions including specification and delivery of overview databases, outputs and response to regulatory questions
  • Produce and maintain technical database standards and programming specification documents
  • Lead/Contribute to the development of best practice to improve quality, efficiency and effectiveness
  • Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB)
  • Planning and executing the transfer and analysis of data for safety/efficacy monitoring boards/independent data monitoring committees

Requirements:

To succeed in this role, you'll be an experienced programmer with good knowledge 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.
  • 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 the ability to influence stakeholders
  • SAS programming expertise gained within a clinical drug development or healthcare setting
  • Knowledge of CDSIC standards and industry best practices
  • Knowledge of database set-up and report publishing requirements

Why AstraZeneca?

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.

AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.

So, what's next?
  • 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?

Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd

Our Social Media, Follow AstraZeneca on LinkedIn https://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



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