Senior Statistical Programmer - V&I

at  AstraZeneca

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 and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects
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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.
Do you have passion for Programming and consider yourself an SME? Would you like to apply your skills to impact drug development process and regulatory interactions in a company that follows the science and turns ideas into life-enhancing medicines? Then AstraZeneca might be the one for you!
AstraZeneca is a global, science-led, patient-centric biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines. Join the team dedicated to Vaccines and Immune Therapies, with an ambition of developing and delivering transformative vaccines and antibodies, providing long-lasting immunity to millions of people, where the burden of disease is greatest.

ESSENTIAL REQUIREMENTS

You are focused on solving challenging problems through collaboration and partnerships. You are a specialist in your field, or aspire to be a specialist, and you know that the best results are achieved by utilising the strengths of every individual.

• Degree in Mathematics (i.e., Applied Math, Engineering, etc.), Computer Science, Statistics, Life Sciences or similar area
• Strong experience in clinical drug development or healthcare
• Advanced SAS Programming, CDISC standards knowledge and industry best practices
• Excellent interpersonal skills

RESPONSIBILITIES:

You will be working in the Vaccines and Immune Therapies Biometrics Programming department providing statistical programming support and/or leading activities related to the analysis and reporting process at project/study level for the delivery of the statistical programming aspects of clinical development. The scope of work includes, but is not limited to, clinical study report development, regulatory submissions, commercialization, and the scientific utilization of our data for AstraZeneca products. There are many career options that can be pursued for development and progression.

WHAT YOU’LL DO

• Lead Statistical programming deliverables for Regulatory submissions, including specification and delivery of datasets, outputs and response to regulatory questions; commercialisation and reimbursements
• Lead Statistical programming deliverables for 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, following applicable data standards and regulations
• Lead Statistical programming deliverables for Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB)
• Contribute to the statistical programming thinking, analysis and reporting to relevant groups in product and study teams
• Contribute to the development of standard methodology to improve quality, efficiency and effectiveness
• Measure compliance to standards and automation use
• Employ good project management practices (estimation, risk management, status tracking) when planning and leading delivery
• Hold CRO/Partners accountable for the high-quality standards of their deliverables.

DESIRABLE FOR THE ROLE

• Experience working in the Respiratory or Immunology therapeutic area
• Other programming languages e.g. S-PLUS, R, Python, XML etc.
• Extensive knowledge of Pinnacle 21 Validator