Principle Clinical Data Scientist

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.

Introduction to role

As a Principal Clinical Data Scientist, you will be responsible for developing Central Monitoring (CM) functionalities of increasing complexity and may coordinate the work of other personnel developing standard and/or study-specific functionalities. You will provide guidance to more junior CM personnel and act as a subject matter expert for selected CM functionalities. Working closely with RBQM leads and other Data Scientists, your proactive approach to sharing insights and experiences with colleagues, both within and outside the department, is crucial. Your role involves overseeing various projects and tasks and implementing process improvements to support an integrated cross-functional approach to managing quality in clinical study conduct and reliability of study results to support publications and regulatory submissions.

Accountabilities

• Working independently and taking responsibility for specific deliveries within a study or project.
• Designing, developing, and leading the development of data mapping to CM functionalities. Tasks can involve gathering requirements, programming, testing, documentation, and coordination of work of other involved personnel.
• Maintenance of data mapping and study-specific CM analyses to ensure they continue to work in line with requirements; acts as a subject matter expert.
• Demonstrating a strong understanding of broader CM strategy and contributing to it by driving cross-functional innovation/optimization projects.
• Staying informed on the data quality needs of regulatory agencies, collaborators, clients, and team members.
• Providing Clinical Data Scientists with guidance on the design and development of data mapping and CM functionalities.
• Having a comprehensive understanding of the CM analytical framework.
• Leading activities related to the development of CM functionalities for a study or project including overseeing the work of more junior staff, delegating tasks between other engaged team members.
• Identify gaps, lead initiatives, and promote new ways of working, improving standard methodologies with new technologies for enhanced quality management.
• Guide the evolution of CM methodology and processes to deliver medicines by applying critical thinking, collaboration, and communication skills.
• In collaboration with Senior Data Scientist, developing and applying novel CM analyses.
• Contributing to the function by training and mentoring more junior staff.
• Leading the quality of own deliverables and overseeing the quality of more junior CM team members.

Essential Skills/Experience

• Educational degree (BSc/MSc/PhD) in Life Science, Computer Science or Information Science and a minimum 5 years of experience in the application of information and knowledge management in a clinical or scientific setting, or equivalent combination of education and experience.
• Good understanding of clinical development, risk-based monitoring, and centralized monitoring methodologies.
• Advanced knowledge of R programming language.
• Excellent communication skills in both written and spoken English.
• Project Management skills.
• Ability to mentor, train, organize, and lead teams.
• Advanced knowledge of SQL and Spotfire (or other Advanced Analytics Platform(s)).
• 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 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

• Minimum of 3 years' experience in the application of information and knowledge management to support Risk-Based Quality Management and/or Centralized Monitoring.
• Previous experience with R Shiny.
• Previous experience with Business Analytics Software, e.g., Power BI / Spotfire / Tableau is an advantage.
• Previous experience with Software Development Lifecycle and computer systems validation.
• Previous experience in life science and clinical studies is an advantage.
• Experience with advanced analytics approaches (e.g., machine learning/AI).

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.

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.