Statistical Science Director – Late CVRM

Locations: Gaithersburg, Maryland or Durham, North Carolina (US)

Competitive salary and benefits package on offer.

Do you have a passion for science, statistics and leadership? Are you up for the challenge to impact a company that follows the science and turns ideas into life changing medicines? If yes, we welcome you to join AstraZeneca!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide, while applying leading edge approaches to science across many business areas. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to act, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world’s most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world.

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.

Our Late CVRM Biometrics team is dedicated to the development of innovative treatment of Cardiovascular, Renal and Metabolic (CVRM) diseases. You will join a global, diverse and cross-functional environment where you will get personal and professional development.

What you will do:

The Statistical Science Director has sufficient experience working as a statistician in the pharmaceutical industry to be accountable and independently lead the statistical strategy or technical activities related to design, delivery and interpretation, high level internal governance committees and/or regulatory submissions of a project or be recognised externally as a methodology expert. This individual is able to lead, perform and communicate results of more technical analyses, and able to guide less experienced staff. Competent individual contributor with excellent cross-functional collaboration.

The Statistical Science Director may lead a project and/or support statistical methodological advances.

The accountabilities for supporting projects directly include:

• Lead the statistical design and strategy to product development plans, preclinical studies, regulatory strategy, health technology assessment and/or commercial activities as appropriate for the stage of the product.
• Lead the statistical content and ensure quality for study designs, documents, delivery and interpretation and submission
• Quantify the benefit, risk, value and uncertainty of the emerging product profile and can communicate these effectively within the team
• Provide global leadership to others and direct project work delivered by internal and external staff
• Partner with CROs to ensure delivery to quality and time
• Represent AZ externally which may include health authorities, advisory boards, conferences, workshops and/or payer interactions
• Maintain knowledge of statistical methodology in relevant areas and promote, investigate and implement novel statistical approaches
• Represent statistical strategy and decision making at internal decision-making governance including review boards, therapy area leadership teams and ESPC/LSPC
• Mentor/coach and support the technical education and training of Statistics staff
• The accountabilities for supporting statistical methodological advances are (technical focus):
• In depth knowledge of technical/regulatory requirements with experience in pharm/healthcare
• Up to date and implements novel stats approaches
• Experience with and broad awareness of regulatory interactions and/or submissions

Essential in the role:

• The minimum required education is a M.Sc./PhD degree in a relevant discipline such as statistics, biostatistics, or mathematical statistics, with exemplary technical skills.
• Knowledge of technical and regulatory requirements with experience in pharmaceutical development, health care, or other relevant areas.
• Excellent communication and influencing skills.
• A track record of independent leadership and initiative, previous managerial experience is not essential.
• Excellent collaborative skills
• Forward thinking awareness of the pharmaceutical landscape
• Willingness to travel domestically and internationally

Why AstraZeneca?

It’s a place to think differently – to find new ways of handling and treating diseases. We are trusted and empowered to explore. Ultimately, it’s more than a job. We know that our work impacts people with serious conditions, many of whom have no other alternatives. That’s what drives us – the potential to impact over one billion patients worldwide.

Where can I find out more?

Follow AstraZeneca on LinkedIn: https://www.linkedin.com/company/1603/

Follow AstraZeneca on Instagram: https://www.instagram.com/astrazeneca_careers/?hl=en

Read more about BioPharmaceuticals R&D: https://www.astrazeneca.com/r-d.html

Please visit our Biometrics landing page: https://careers.astrazeneca.com/biometrics

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.