Director, Real World Evidence (RWE)

Role Summary

We are seeking a highly skilled and motivated Scientific Director to join our RWE team. The successful candidate will apply advanced statistical methods to support algorithm development, patient stratification, innovative trial design and novel endpoint development for neuroscience. This role will help shape the next generation of data-driven solutions for neuroscience drug discovery and development, working closely with the Neuroscience Therapeutic Area, Clinical Development, Quantitative Sciences, Regulatory and Patient Reported Outcomes.

Responsibilities

• Design, develop, and validate statistical approaches and algorithms for patient stratification, leveraging both clinical trial and real-world datasets.
• Lead the statistical design, analysis, and validation of novel digital endpoints (e.g., wearables, speech, cognition) for neuroscience.
• Partner with our multidisciplinary team to ensure biological and clinical relevance of patient stratification strategies and novel endpoints.
• Apply rigorous statistical methodologies to algorithm development, ensuring reproducibility, robustness, and regulatory readiness.
• Develop and maintain statistical analysis plans, simulation studies, and innovative methodologies tailored to multimodal datasets.
• Apply advanced statistical and machine learning methods to large-scale datasets, including EHRs, claims, registries and longitudinal cohort studies.
• End-to-end expertise in RWE research including conceptualizing research questions, data feasibility, study design, analysis, programming, and interpretation.
• Communicate findings and methodologies clearly to scientific, clinical, and non-technical stakeholders.
• Contribute to regulatory submissions, publications, and presentations at internal and at scientific meetings.
• Stay current with emerging statistical methodologies, regulatory guidance, and best practices in RWE.

Qualifications

• Ph.D. or Master’s in biostatistics/statistics, epidemiology, or related field.
• 8+ years of experience in pharmaceutical, biotech, RWE consulting or healthcare analytics.
• Expertise in statistical modeling including inference, Bayesian methodologies, time series analysis and functional data analysis approaches. Knowledge of state-of-the-art AI methodologies is an advantage.
• Experience working with real-world data (EHR, claims, registries, digital health) and familiarity with their opportunities and limitations.
• Knowledge of endpoint validation frameworks and regulatory requirements (e.g., FDA/EMA) is highly desirable.
• Proficiency in statistical programming languages (R, Python, SAS, or equivalent).
• Demonstrated ability to work in a cross-functional environment, with excellent communication and collaboration skills.
• A track record of scientific impact through publications, conference presentations, and/or regulatory interactions.
• Experience working with neuroscience datasets (e.g., MRI, EEG, digital cognitive measures, biomarkers) and understanding of their clinical context is desired.