Director, Real World Evidence (RWE)

Johnson & Johnson•Cambridge, MA

56d

About The Position

At Johnson & Johnson,â we believe health is everything. Our strength in healthcare innovation empowers us to build aâ world where complex diseases are prevented, treated, and cured,â where treatments are smarter and less invasive, andâ solutions are personal.â Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.â Learn more at https://www.jnj.com About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine 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.

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.

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.