Associate Director, Statistical Programming
5 months ago
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.
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.
AstraZeneca is a global, 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.
**Main Duties and Responsibilities**
In this role, we will give you the chance to utilize your statistical programming expertise in analysis and reporting of clinical trials and exploratory analyses to manage and generate evidence to support our product portfolio.
**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 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, following applicable data standards and regulations
- Lead Statistical programming contribution to Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB)
- Contribute to or lead the statistical programming thinking, analysis and reporting to relevant groups in product and study teams
- Lead development of standard methodology to improve quality, efficiency and effectiveness
- Drives standards development, implementation, and measure compliance to them
- Provides inputs to capacity management while supporting recruitment and skill development by providing training and mentorship
- 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.
**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
- Extensive experience in clinical drug development or healthcare
- Advanced SAS Programming, CDISC standards knowledge and industry best practices
- Excellent interpersonal skills
**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 Pinnacle21 Validator
**Great People want to Work with us Find out why**:
- GTAA Top Employer Award for 10 years
- Top 100 Employers Award
- Canada’s Most Admired Corporate Culture
- Learn more about working with us in Canada
- View our YouTube channel
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