[Innovative Medicine] Data Scientist, Evidence Generation, Medical Affairs Div.

Data Scientist, Evidence Generation 

Position Summary: 

The Data Scientist will serve as the Data Science and Biostatistics lead for Real-World Evidence studies conducted by Medical Affairs, including prospective observational studies and database studies. The role is responsible for providing scientific and analytical leadership throughout the evidence generation lifecycle, from study planning and execution through data analysis, publication, and scientific communication. 

Working closely with Therapeutic Area (TA) teams and other cross-functional partners, the Data Scientist will contribute to evidence generation activities aligned with TA strategy and Integrated Evidence Generation Plan (IEGP). The role will also support the advancement of data science and biostatistics capabilities, processes, and innovative approaches within Medical Affairs. 

Key Responsibilities: 

• Serve as the Data Science and Biostatistics lead for assigned Medical Affairs studies, ensuring alignment with TA strategy and IEGP. 

• Provide scientific and analytical input into study concepts, protocols, data collection strategies, and analysis plans. 

• Develop or oversee the development of Statistical Analysis Plans (SAP) aligned with study protocols and research objectives. 

• Review statistical programming and the delivery of high-quality tables, figures, listings, and analytical outputs in a timely manner. 

• Work closely with external service providers to ensure quality and timely delivery of statistical and data science activities. 

• Contribute data science, biostatistics, and epidemiological perspectives to the development of IEGP, Key Research Questions, and new study proposals. 

• Lead or provide expert input into the interpretation of study results and communication to internal and external stakeholders. 

• Contribute to manuscripts, abstracts, posters, oral presentations, and other scientific communications, fulfilling applicable author or contributor responsibilities. 

• Lead process improvement and capability-building initiatives related to data science, biostatistics, and evidence generation. 

• Promote fit-for-purpose analytical approaches, innovative methodologies, and the effective use of relevant data and digital technologies. 

• Proactively identify opportunities and challenges in evidence generation and propose new data science, biostatistics, or process improvement initiatives. 

Required Qualifications and Experience: 

• Master’s degree in a relevant field such as biostatistics, epidemiology, data science, or medicine. 

• 4 years of relevant experience or demonstrated ability to independently lead evidence generation studies as a data scientist, biostatistician, or comparable quantitative professional in the pharmaceutical industry, healthcare sector, academia, CRO, or related environment. 

• Strong knowledge of data science and biostatistical principles and methods. 

• Experience developing or reviewing SAP and statistical outputs. 

• Hands-on proficiency in statistical programming and data visualization using relevant languages and analytical software, such as SAS, R, SQL, or equivalent tools, combined with the ability to independently develop and execute robust statistical analysis plans. 

• Working knowledge of epidemiology, study design, and clinical research principles. 

• Candidates whose analytics experience is primarily in a commercial setting may be considered if they can independently develop and execute a robust statistical analysis plan for large-scale healthcare or real-world datasets. 

• Ability to collaborate effectively with a broad range of stakeholders in a cross-functional and matrix environment. 

• Strong problem-solving skills, strategic thinking, and attention to detail. 

• Business-level communication skills in both Japanese and English. 

• Commitment to the Johnson & Johnson Credo and its values. 

Preferred Qualifications and Experience: 

• Ph.D in a relevant field such as biostatistics, epidemiology, data science, or medicine. 

• Experience leading an evidence generation study from initial planning through analysis, publication, or scientific communication. 

• Experience overseeing CROs or other external service providers for statistical analysis or data science activities. 

• Experience contributing to manuscripts, congress abstracts, posters, or presentations. 

• Knowledge of advanced analytical methodologies. 

• Experience working with regional or global cross-functional teams. 

The role involves extensive interactions with: 

• Study team members in Medical Affairs (TA, PADU, DM) 

• Local, regional and global Data Science, Biostatistics, Epidemiology, R&D 

• External research partners (CROs, data providers) 

• Medical Affairs Leadership Team 

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