Customer Data Lead overseeing client - specific data operations for CUBE's regulatory data services. Ensuring best - in - class data services across North America.
JJ
Hybrid Director, R&D Data Science – Digital Health, Real-World Evidence, Neuroscience
Posted last month
About the role
- Director of R&D Data Science & Digital Health driving innovative evidence solutions at Johnson & Johnson. Leading advanced analytics to support neuroscience drug discovery.
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.
Requirements
- 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.
Benefits
- medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance
- Company’s consolidated retirement plan (pension)
- Company’s savings plan (401(k))
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
- Caregiver Leave – 10 days
- Volunteer Leave – 4 days
- Military Spouse Time-Off – 80 hours
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