Director, Real World Data Science

Job Title: Director, Real World Statistics

Introduction to role:

Are you ready to make a difference in the world of rare diseases? Join the Epidemiology and Real World Science team within Alexion-AstraZeneca Rare Disease Unit, where we harness the power of Real World Data to redefine patient access to innovative medicines. As Director of Real World Statistics, you'll focus on statistical applications supporting our rare disease portfolio, emphasizing disease registry initiatives and regulatory submissions. With AstraZeneca's rich history in Real World Evidence, you'll be part of a dedicated capability with strong statistical foundations and extensive experience in regulatory applications. Are you curious and determined? Bring your expertise in disease registries and longitudinal observational cohorts to provide statistical methods expertise, mentor junior statisticians, and deliver robust analyses that meet regulatory standards.

Accountabilities:

• Design and implement advanced statistical analyses for regulatory submissions using data from disease registries, patient registries, natural history studies, EMR, and claims data.
• Collaborate with registry teams and support Alexion in regulatory interactions, ensuring registry-derived analyses align with regulatory strategy.
• Prepare regulatory-quality results including statistical reports and clinical study reports based on registry analyses.
• Develop and validate statistical methodologies for real-world evidence generation from registry sources.
• Mentor junior statisticians and data scientists in regulatory-compliant registry data analysis techniques.

Essential Skills/Experience:

• Doctoral degree in Biostatistics, Statistics, Epidemiology, Mathematics, Data Science, or related field with at least 6 years in the pharmaceutical industry, biotechnology, or consulting environment; or Master’s degree in Computer Science, Statistics, Mathematics, Data Science, or related field with at least 10 years industry experience in the pharmaceutical industry, biotechnology, or consulting environment.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Desirable Skills/Experience:

• Hands-on technical expertise with proficiency in statistical programming languages (R, SAS, SQL) and regulatory-compliant programming standards.
• Proven track record of successful regulatory submissions incorporating registry data.
• Extensive experience with regulatory applications of disease registries and natural history studies.
• Deep familiarity with regulatory standards and guidelines including ICH guidelines, FDA Real-World Evidence Framework, EMA guidance on registry-based studies.
• Strong background in regulatory statistics with specific expertise in registry-based regulatory submissions.
• Demonstrated ability to build long-term relationships with regulatory agencies and lead multi-disciplinary regulatory-focused statistical projects.

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 we need 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.

At AstraZeneca, you'll find a culture that champions diversity and inclusion. Our patient-driven ethos fosters connections that lead to groundbreaking ideas impacting patients' lives. We celebrate each other's successes and ensure kindness is as vital as our ambition. With tailored development programs and a supportive community of leaders and peers, you'll be empowered to make a meaningful impact. Here, your career is not just a path but a journey to making a difference where it truly counts.

Ready to join us on this exciting journey? Apply now and be part of a team that's redefining the future of healthcare!

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.