Pharmacoepidemiologist (with quantitative focus)

Do you have expertise in, and passion for drug safety and real-world evidence (RWE)? Would you like to apply your expertise to evaluate the safety of medicinesin a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods, and bringing unexpected teams together. Interested? Come and join our journey. Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

The Pharmacoepidemiologistis a scientifically-driven vital position, accountable for driving scientific and operational aspects of post-authorisation safety studies (PASS) and post-marketing commitments/requirements (PMCs/PMRs) utilising RWE, including the use of large electronic healthcare data (EHR) to support various pharmacovigilance and regulatory activities.

The incumbent will be responsible for developing and/or leading global strategy and deliverables across various products in the AZ Biopharmaceuticals portfolio and will also support and coordinate with local markets on mandated PASS requiring local RWE data. They will work closely with cross-functional internal stakeholders across Global Patient Safety, Global Regulatory, Global/Local Medical, and R&D to develop strategic plans for using epidemiological tools and methods. They will also ensure studies are designed and implemented in accordance with the regulatory requirements in anticipation of requests from EMA, FDA, and other regulatory agencies. The incumbent will provide scientific guidance and direction for pharmacoepidemiology, collaborating with colleagues and peers from a wide variety of disciplines to ensure optimal management of relevant studies.

In addition, the pharmacoepidemiologist would have responsibilities over conducting rapid healthcare analytics using large electronic healthcare data using R or through an in-house analytical platform, for the purpose of supporting drug development and/or responding to healthcare authority (e.g., FDA, EMA, etc) requests.

The Pharmacoepidemiologist must be able to

• Provide strong, detailed guidance for optimizing pharmacoepidemiology and pharmacovigilance study design and execution

• Develop design and drafting of protocols and a broad range of observational research including primary data collection and secondary use of data

• Conduct ad hoc literature reviews on Patient Safety related RWE and related matters

• Leverage large electronic healthcare data to conduct rapid healthcare analytics, using a consultative and problem-solving approach, working under tight deadlines with imperfect information

Essential Requirements

• Ph.D. or equivalent in pharmacoepidemiology, epidemiology or related health science field withsubstantial experience analysing large electronic healthcare data.

• Strong background in epidemiological theory and methods, including appropriate use of medical statistics to solving problems in epidemiology

• Conceptual understanding of secondary data and/or primary data collection studiesto design and conduct post-authorisation safety studies

• Able to provide a robust literature review and perform critical appraisals to published studies

• Ability to work effectively withcolleagues from a wide variety of disciplines

Desirable Requirements

• Prior work experience as a pharmacoepidemiologist or quantitative epidemiologist

• Ability to work independently to achieve specific research objectives

• Experience planning, analysing and interpreting results of statistical analyses performed using large electronic healthcare data

• A solutions-oriented approach to using imperfect data, coming up with pragmatic ways forward to reach research objectives

• Ability to work under pressure to generate results quickly to support health authority requests and/or insights needed to further clinical development

• Working knowledge of epidemiological methods used in research in drug development or in a closely related academic research area