Statistical Programming, Therapeutic Area Standards

3 weeks ago

Mississauga, Canada AstraZeneca Full time

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, science-led, patient-centric biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines. Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. With multiple indications and high-quality molecules in all stages of our innovative pipeline, we keep pushing forward to conquer cancer through data, innovation and evidence-based decisions.

**Role**

You will be working in the Oncology Biometrics Programming department reporting to a Sr. Director, Statistical Programming, providing leadership and management of standards governance activities at the therapeutic and study level related to the planning, execution and delivery of the data and the analysis reporting of clinical development.

AstraZeneca are currently redefining our clinical data flow, and this puts standards at the center of the process. The TASAL role will play a critical part in ensuring that our standards and the governance process are fit for purpose as these will form a key enabler for efficiency and automation initiatives.

The scope of work includes, but is not limited to, the governance of clinical data standards change requests, development of new Oncology TA standards, and participation in cross-TA standards development activities.

**Essential for the role**

To succeed in this global role, you need to be an enthusiastic individual with an understanding of technical and regulatory requirements related to programming within the pharmaceutical or healthcare industry. You should enjoy multitasking and collaborating with others and have experience with solving problems and resolving conflicts.
- Bachelor’s or Master’s (or local equivalent) degree in Mathematics, Statistics, Computer Science, Life or Social Sciences or related field
- Support the Oncology Therapeutic Area Standards Definition Team by reviewing change requests from oncology study teams for standard components (with focus on SDTM, ADaM, TLF) to ensure compliance with the AZ & CDISC standards, regulatory guidelines and AZ Clinical data standards SOP, Protocol/SAP
- Support study teams with questions related to oncology standards (with focus on SDTM, ADaM, TLF)
- Participate in and contribute to working groups (including SME’s) during review and optimisation of existing Corporate and Oncology Standards
- Participate and contribute in working groups (including SME’s) during development of new Oncology standards (e.g. haematology and cell therapy)
- Standards development (e.g. SDTM/ADaM, TLF) in collaboration with SMEs to ensure alignment with key TA documents e.g. SAP
- Participate and contribute to the development of programming tools Corporate and Oncology) to facilitate automation.
- Standards improvement, end-to-end, collaborative, problem-solving mind-set.
- Strong communication, leadership and influencing skills.

**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
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