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Statistical Programming Associate Director - CVRM

Hybrid Work- on average 3 days/week from office Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown (temporary) office

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Are you an experienced Statistical Programmer with good knowledge of clinical drug development? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to impact a wide range of engaging projects striving to make a difference for millions of patients. Our Biometrics team consists of Statisticians, Programmers, Information and Data Scientists. We drive and contribute to optimized clinical drug development programs and access to information and scientific knowledge management.

Introduction to the role:

This role is a delivery focused technical leadership role for programming and overseeing deliverables with quality and timeliness, following established standards and processes. This leadership role requires profound programming experience and excellent industry knowledge to independently lead implementation of programming activities and guide other programmers. You will provide subject matter expertise within the Programming discipline and act as a specialist within cross-functional teams to deliver continuous improvement.

Typical Accountabilities:

You are responsible for leading and advising the full scope of project delivery and/or lead a technical project within the Therapeutic Area (T/Drug Project/Study/Function.

Leading implementation of statistical programming aspects of the protocol or clinical development program

Responsible for the high quality of all project results, holding partners and providers accountable for the quality of their work or technical subject matter expert for aspect(s) of the TA, Project, or function

Leading or contributing to cross-functional administrative or process improvement initiative(s)

Driving the development of standard processes to improve quality, efficiency and/or effectiveness within the function

Driving standards development and implementation

Providing technical expertise to the team

Providing tactical inputs and/or driving ideas and improvements

Contributing to the function by supporting recruiting and/or providing training and mentorship

Finding opportunities to improve methodology and provides practical solutions for problems

Handling activities of our external partners (i.e. Contract Research Organisations)

Influencing partners by providing subject matter expertise on programming related items

Ensuring compliance to standards and automation usage

Employing all project management practices in running drug or technical projects

Providing input to capacity management for all projects in scope

Maintaining expertise of the latest industry and regulatory requirements to stay current

Education, Qualifications, Skills, and Experience:

Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science, or equivalent

At least 7 years of relevant experience

Excellent programming skills in SAS (or R) and SAS macros

Thorough knowledge of the clinical development process

knowledgeable of industry standards (CDISC) and ability to implement them

Ability to apply programming expertise to problem solving and troubleshooting for teams

Current knowledge of technical and regulatory requirements relevant for the role

Ability to proactively handle concurrent activities within a project

Proficient ability to influence relevant partners on programming related items

Ability to handle risk in complicated or novel situations

Project Mindset

Desirable Skills/Experience:

Broad experience across multiple therapeutic areas and across all phases of clinical trials

Experience in regulatory submissions and interactions

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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by  emailing AZCHumanResources@astrazeneca.com.

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.