Senior Statistician Ii

Senior Statistician II - Late Oncology

Location: Macclesfield, UK or Warsaw, Poland

Competitive salary and benefits

**Play a critical role in making our pipeline accessible to patients.**

AstraZeneca is a global, **science-led, patient-focused biopharmaceutical company **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 dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It’s our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025.

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.

**Main Duties and Responsibilities**

As a Senior Statistician, you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives.

Focus & Challenge of Position
- Provide statistical leadership in support of the Global Product Statistician (GPS), be a newly appointed GPS, or lead strategic capability or business area improvements with mínimal supervision
- Serve as primary author for statistical sections of protocol concept sheets (PCS), protocols, clinical development plans (CDP), and integrated product development plans (iPDP)
- Perform statistical analyses and create statistical text for clinical publications and other communications
- Provide direction and statistical oversight to outsourcing partners/providers regarding requirements and standards for study-level work, holding partners/providers accountable for the quality of their deliverables
- Define and lead analysis of relevant internal and external information to inform design decisions
- Provide statistical support and leadership to clinical trial teams (CTT), clinical sub-teams (CST) and product development teams (PDT) on the development of Target Product Profile and Target Product Claims (TPP/TPC), Benefit, Risk, Value and Uncertainty (BRV(U)), clinical development plans (CDP), and regulatory strategy
- Lead development of components of regulatory submissions (eg, briefing documents, response to FDA requests, BLA/NDA, and sBLA/sNDA) and may represent AZ Statistics to Health Authorities (eg, Pre-IND and End of Phase II meetings)
- May provide highly experienced expert statistical leadership to the development of the capability area and to PDTs, promoting good statistical practice
- To represent the company’s position in their contacts with external experts
- May also participate in providing statistical support/strategy for post-marketing/Medical Scientific Affairs activities
- Requires juggling multiple projects with varying priorities. Requires ability to recognize issues that may critically affect statistical analyses and to relay that information to appropriate level of management
- Minimal supervision, appropriately and pro-actively consulting with key stakeholders (eg, GPS) and line management where needed to ensure a successful outcome to agreed time, cost and quality

**Knowledge, Skills & Experience Required**
- MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in pharma/healthcare or other relevant area
- In depth knowledge of the technical and regulatory requirements related to the role
- Expert leadership capabilities to be able to lead and direct project work
- Extensive experience of Development, programme design and data analysis and interpretation
- Experience of major regulatory interactions and/or submissions
- Excellent communication skills and ability to build strong relationships
- Excellent collaboration skills required - the energy to work across global & functional boundaries, both internally and externally

**Why AstraZeneca?**

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

**So, what’s next?**
- Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
- Are you ready to bring new ideas and fresh thinking to the table? Bril