Associate Director, Epidemiology (12-Month Contract)

Note*** This will be a 12-month contract.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week 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.

This position is accountable for the timely preparation of high-quality regulatory compliant clinical document deliverables for Alexion Rare Disease Unit (Alexion). This position will support the medical writing (MW) activities for one or more clinical programs. This position will function with supervision and guidance from experienced managers or colleagues.

Introduction to role

The Associate Director, Epidemiology is a strategic and scientific leader responsible for developing, coordinating, and completing impactful epidemiology deliverables within Alexion’s registries and post-approval studies. This role involves overseeing the development, incorporation, and analysis of data from rare disease registries and post-approval studies, either personally or through the management of other epidemiologists or vendors. The goal is to enhance the understanding of disease natural history, treatment outcomes, and drug safety evaluations. The Associate Director ensures all deliverables are completed efficiently, within budget, and with high quality and accuracy. The job entails collaborating with various teams and engaging with external customers to effectively communicate epidemiological issues and study results.

Accountabilities

• Responsible for developing and completing Epidemiology deliverables from Alexion’s registries and/or post-approval studies

• Coordinate and oversee the planning and execution of analyses from Alexion’s registries and/or post-approval studies. Provide oversight and guidance to statisticians and programmers in development of analytic deliverables.

• Propose, design, initiate, complete, and report epidemiologic study analyses performed within observational studies, registries, or external databases for their assigned indication(s)

• Summarize results in written reports and oral presentations.

• Provide epidemiology support to Clinical Development, Patient Safety, Regulatory Affairs, Medical Affairs, and Commercial activities across the development life cycle. Active participation on cross-functional therapeutic area teams. Lead sub-team meetings as appropriate.

• Provide epidemiology perspective into study protocols, case report forms (CRFs), and regulatory documents for their assigned indication(s).

• Interact with authors and in-house reviewers on scientific manuscripts, clinical conference abstracts, presentations, and posters based on data from observational studies.

• Represent the Epidemiology and Real World Science department when interacting with key external collaborators such as Scientific Advisory Boards and regulatory authorities.

• Critically appraise and synthesize relevant epidemiological literature.

• Maintain awareness of epidemiology with respect to regulatory requirements, payer trends, and advancement of pharmacoepidemiology methods.

• Travel may be required (up to 10%).

Essential Skills/Experience

• At least 3 years of industry experience in the pharmaceutical industry, biotechnology, or consulting environment for Doctoral-level candidates, or 6 years of industry experience for Master’s-level candidates

• PhD / DSc / DrPH in Epidemiology with 3 years of industry experience, OR MPH / MSc in Epidemiology with 6 years of industry experience

Desirable Skills/Experience

• Excellent oral and written communication skills

• Knowledge of drug and clinical development process

• Excellent attention to detail and quality, and scientific rigor

• Excellent analytic, project planning and problem-solving skills

• Ability to work under pressure and lead by example

• Strong interpersonal skills and ability to work effectively in multidisciplinary teams

• Thorough and up-to-date technical knowledge of epidemiology and biostatistics methods

• Experience and familiarity using SAS for statistical analysis

• Record of high-quality publications in peer-reviewed journals

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

#LI-Hybrid

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Annual base salary for this position ranges from 138,240.00 to 181,440.00.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.