.Statistician / Senior Statistician / Principal Statistician (all levels) - Late R&I Location: Barcelona, SpainPlay 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 diseases. Our Late R&I Biometrics team is dedicated to the development of innovative treatments for Respiratory and Immunology (R&I) diseases.You will join a global, diverse and cross-functional environment where you will get personal and professional development. 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 ResponsibilitiesAs a Statistician / Senior Statistician / Principal Statistician, you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives.Provide statistical support to the Global Product Statistician (GPS), be a newly appointed GPS (as Principal Statistician only), or lead strategic capability or business area improvements.Serve as primary author for statistical sections of Clinical Study Protocols (CSPs), clinical development plans (CDP), or Statistical Analysis Plans (SAPs).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.Development of components of regulatory submissions (e.G., briefing documents, response to FDA requests, BLA/NDA, and sBLA/sNDA).May provide highly experienced expert statistical leadership to the development of the capability area, 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 and the ability to recognize issues that may critically affect statistical analyses and to relay that information to appropriate management levels.Independent working, appropriately and pro-actively consulting with key partners (e.G., GPS) and line management where needed to ensure a successful outcome to agreed time, cost and quality
