Statistical Science Director – Late Vaccines & Immune Therapies

at  AstraZeneca

PLAY A MEANINGFUL ROLE IN MAKING OUR PIPELINE ACCESSIBLE TO PATIENTS.

Do you have expertise in, and passion for, Biostatistics? Would you like to apply your skills to impact all phases of drug development and regulatory interactions, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
The Vaccines and Immune Therapies unit has been built to optimize AstraZeneca’s portfolio of vaccines and antibodies for infectious diseases. We are committed to focusing on vaccines and infectious diseases, developing and implementing scientific advancements.
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

In this role you will be responsible in owning the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation for indications/projects within an AZ product team.
You will provide leadership to statistical staff on the indications/projects so that all work is carried out with regards to AZ standards and external regulations; through partnership with experts, developing design options and providing high quality decision support to enable the business to make informed decisions; quantifying the benefit, risk, value and uncertainty of the emerging product profile.
You will be holding CRO/Partners accountable for the high quality standards of their deliverables. You will represent AZ and Statistics to Health Authorities and Reimbursement/Payer Organizations for specific projects/indications.
You will apply expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration. You will mentor/coach and support the education and training of Statistics staff in the technical arena.

DESIRABLE IN THE ROLE, DEPENDENT ON EXPERIENCE:

• Experience of programme and study design
• Experience in the relevant therapeutic area
• Experience of regulatory interactions
• Prior Vaccines experience would be beneficial