Director, Real World Evidence (RWE)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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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.

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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.

Key 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 Masters 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

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