Statistical Science Director – Late Vaccines & Immune Therapies

Location: Gaithersburg or Waltham (US) or Mississauga (CA)

Competitive salary and benefits

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.

Requirements

Essential

• MSc or PhD degree or equivalent experience in Statistics, Biostatistics, or related quantitative fields, or equivalent course work/ technical experience
• Understanding of regulations/developments in the area of Clinical Development and Biostatistics
• Appropriate experience as a statistician for the relevant position level with clinical trials, pharmaceutical development, regulated research, and/or related areas of statistical applications
• A collaborative attitude
• A general dedication to and ability to apply expertise to problem solving
• Experience with relevant statistical software
• Ability to apply statistical techniques in the analysis of data from clinical studies or other significant are

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

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.

Onsite position

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world!

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? Brilliant! We have one seat available, and we hope it’s yours.

Where can I find out more?

• Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
• Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
• Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
• Our dedicated Biometrics page https://careers.astrazeneca.com/biometrics

Date Posted

21-Mar-2024

Closing Date

29-Apr-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.