Associate Director, Quantitative Science and Biometrics - Evinova

AstraZeneca•Gaithersburg, MD

6d•Hybrid

About The Position

As an Associate Director Scientist within Evinova Endpoints, you will serve as a subject matter expert in Clinical Outcome Assessments (COAs) and quantitative evidence generation spanning statistical analyses, endpoint development, and data management for both established and novel endpoints. You will lead advanced COA analytics that articulate the patient benefit of new medicines, directly shaping the development and commercialization of innovative therapies and digital health solutions. You will set strategic oversight for quantitative evidence generation at both study team and therapeutic area levels, designing analytic approaches to close evidence gaps. Your work will drive quantitative clinical programming for validation and exploratory analyses using biosensor and wearable data and COA data to identify and evaluate symptoms, function, health related quality of life, and other patient centric concepts of clinical benefit across the drug development lifecycle. Therapeutic areas include Oncology, Cardiovascular, Renal and Metabolism, and Respiratory and Immunology, among others. You will own the clinical data flow and management strategy, collaborating closely with product engineers to ensure robust, scalable pipelines. Responsibilities include overseeing project level work through cross functional collaboration, and developing and executing analysis plans to generate evidence that supports clinical validity of endpoints. Success in this role relies on strong partnerships with internal teams such as Study Teams, Strategy, Data Science, COA Measurement, and Product and external stakeholders such as Global and Clinical Study Teams and partners, consistently upholding patient centricity, diversity, sustainability, and scientific rigor.

Requirements

Doctoral degree (e.g., Ph.D., Sc. D. or Dr.P.H.) in a relevant field such as, but not limited to, Science, Statistics, Biostatistics, Psychology, Testing and Measurement, Epidemiology, Pharmaceutical, Neuroscience, or other quantitative-related fields, plus two years relevant and practical experience OR: Masters degree in a related field (as noted above), plus five years practical experience
Proficiency in Programming and Visualization: Skilled in R, SAS, Python, or similar tools for robust data analysis and visualization.
Clinical Evidence Expertise: Capable of interpreting clinical research data and clearly communicating findings to diverse audiences.
Drug Development Insight: Possesses a solid understanding of the drug development process and its stages.
Project Leadership: Demonstrates strong project management abilities, ensuring effective planning, execution, and delivery of results.
Analytical and Strategic Thinking: Excels in conceptual, analytical, and critical evaluation, enabling informed decision-making and problem-solving.
Strategic Influence: Able to lead teams, influence key stakeholders, and thoughtfully persuade to achieve desired outcomes while fostering positive organizational relationships.
Accountability and Initiative: Willing to challenge existing practices, take ownership of tasks, and uphold accountability for both self and others.
Efficiency and Adaptability: Navigates ambiguity and rapidly resolves challenges in a dynamic, fast-paced environment, embracing new ways of working as needed.
Exceptional Communication: Communicates clearly and confidently, with the ability to build productive relationships across teams.
Creativity and Innovation: Brings a solution-oriented mindset, leveraging creative and innovative approaches to drive success.
Diligence: Maintains attention to detail and manages multiple concurrent activities with precision and care.
Resilience: Demonstrates the ability to adapt, overcome challenges, and motivate others within a constantly evolving environment.

Nice To Haves

Experience with data from multiple sources, including wearables and sensors
Understanding of novel digital development framework with experience
Understanding of the regulatory landscape governing research with human subjects
Conducting of outcomes research studies, and the communication of study findings to internal and external audiences

Responsibilities

Develop and implement strategies for quantitative evidence generation at the study team and TA level
Develop analytic approaches to address evidence gaps
Contribute to programming workstreams for psychometrics/clinometric/statistics to generate evidence of patients’ experience with treatment throughout the drug development lifecycle. (e.g. psychometric performance of the instrument, sensitivity/specificity of signal detection, construction of novel endpoints).
Lead workstreams to deliver project-based evidence.
Contribute to the conduct and interpretation of psychometrics/clinometric or statistical analyses for the validation of novel endpoints leveraging data from clinical outcomes assessments (COA) including data from sensors/wearables in clinical trials including: develop analyses strategy, manipulate and validate data files, test selection, and analyses.
With supervision, prepare, review, and publish data and ensure that clinical validation findings are communicated effectively, and as appropriate in scientific reports, internal/ conference presentations, publications, regulatory dossiers reflecting ongoing or completed work

Benefits

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.
Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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