Principal Statistical Programmers - Late stage CVRM

Are you a Statistical Programmer with deep knowledge within clinical development? Would you like to be part of an fast-paced and agile team who has direct strategic impact on drug development, empowered and trusted to innovate? If yes, join us at AstraZeneca Late-Stage CVRM (Cardiovascular Renal Metabolism) Biometrics and get access to our extensive capabilities and comprehensive pipeline where you'll be involved in a wide range of engaging projects aiming to make a difference for millions of patients.

At AstraZeneca, we work at the cutting edge of science to develop the ground-breaking medicines of the future - here we do things that have never been done before. 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, by doing the right things. And we do something that truly matters - using our skillset to make an important difference to society and patients across the globe. We get to make a profound impact with research that makes a clear and tangible difference.

We are now offering exciting opportunities for talented and highly motivated individuals to join us in the role as Principal Statistical Programmers within Late CVRM.

The role can be based at AstraZeneca's dynamic R&D sites in Gothenburg (Sweden) or Gaithersburg (USA).



What you'll do

You will be part of a team of statisticians and statistical programmers and work with providing programming expertise to the design, conduct, evaluation, documentation and regulatory submissions of our clinical development programs. In the role as Principal Statistical Programmer, you will contribute to more strategic planning, quantitative decision making, act as specialist in our contact with external providers and collaborators, mentoring more junior staff, lead projects and be involved in adapting and developing programming tools, standards and praxis.

There are countless learning opportunities here. AstraZeneca is a rapidly growing business, that's investing in all areas, especially technology. 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. If you want to learn every day, this is the right place for you.



Responsibilities

Reporting to a Director within the Statistical Programming group you will provide programming expertise in:

* Lead and directs the full scope of project delivery and/or leads a technical project within the TA/Drug Project/study/function
* Leads Implementation of statistical programming aspects of the of the protocol or clinical development program
* Responsible for the high quality of all project deliverables, holding partners and providers accountable for the quality of their deliverable and/or technical subject matter expert for aspect(s) of the TA, Project, or function
* Leads or contribute to cross-functional administrative or process improvement initiative(s)
* Drives the development of best practices to improve quality, efficiency and/or effectiveness within the function
* Drives standards development and implementation
* Manages and escalate risk in complicated or novel situations within their study and/or projects
* Contributes to the function by supporting recruiting and/or providing training and mentorship
* Identifies opportunities to improve methodology and provides practical solutions for problems
* Manages activities of our external partners (i.e. Contract Research Organisations)
* Influences stakeholders by providing subject matter expertise on programming related items
* Ensures compliance to standards and automation usage
* Employs all project management practices in managing drug or technical projects
* Provides input to capacity management for all projects in scope
* Maintains own knowledge of latest industry and regulatory requirements to stay current



Essential for the role

* BSc in a Mathematical (Applied Math, Engineering, etc.), Statistical, Computer Science or Life Science subject
* Excellent communication skills and ability to influence stakeholders
* Extensive SAS programming expertise (advanced level) gained within a clinical drug development/ healthcare environment
* Comprehensive knowledge of technical and regulatory requirements with submission experience
* Wide ranging knowledge of CDSIC 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
* Planning and organizational skills

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 details and solving problems. You will be an effective communicator, with a strong team focus who enjoys collaborating to achieve the best results.





So, what's next?

Are you already imagining yourself joining us? Good, because we can't wait to hear from you! Welcome with your application (CV and cover letter) no later than April 30th, 2021. We will review the applications continuously so please apply as soon as possible.