RWE Principal Data Scientist

Key Skills

Unix Operating system, Java Programming, Management, Risk Analytics, Python Programming, SQL, Data science techniques, R Programming, Data Analysis

Job Description

The Real World Data Center of Excellence is meant to foster an environment that simplifies and accelerates collaboration-driven insights that enable data driven business decisions by bringing best practices and standardizing approaches to common questions involving real world data.

The Real-World Evidence Observational Data Scientist is responsible for managing the acquisition, processing, and curation of non-Takeda sourced observational RWD, including clinical, claims, disease registry, electronic health/medical records (EHR/EMR) and imaging metadata. The role will manage a wide portfolio of data types, with a goal of supporting diverse analyses across Research & Development (R&D); will ensure data transfers follow quality standards; and will coordinate with other stakeholders in R&D to ensure acquisitions satisfy expected analysis plans. In addition, responsibilities include programming analyses of the RWD, working with observational data sciences colleagues, and collaborating with stakeholders across Takeda, including epidemiologists, translational biologists, biomarker scientists, and biostatisticians. These analyses will provide a better understanding of disease natural history, incidence/prevalence, co-morbidities, treatment patterns, and health and safety outcomes in ‘real world’ patient populations, across a wide variety of serious and unmet diseases, resulting in a high impact to research and early development, clinical development pipeline, and marketed products.

ACCOUNTABILITIES

• Develop and implement enterprise RWE strategies to efficiently address business needs.
• Collaborate internally and externally to address RWE needs and advise on unmet data needs
• Strengthen partnerships with stakeholders within the organization and externally with platform vendors, RWE innovators, FDA etc.
• Act as a knowledge developer and repository around observational studies, FDA policies, publications etc related to RWE.

CORE ELEMENTS RELATED TO THIS ROLE

• Collaborate with external vendors, Takeda partners, and external organizations responsible for collecting the data
• Ensure data transfers follow quality standards and coordinate with other stakeholders in R&D to ensure acquisitions satisfy expected analysis plans
• Define and implement data transfer, quality control and curation processes, and maintain the data quality pipeline
• Collaborate with other team members to ensure consistency of quality control methods and processes across disparate types of data sourced external to Takeda
• Conduct analyses pertaining to the application of the observational RWE data for diverse stakeholders, including Epidemiology, Value & Access, Translational Biology, Biomarkers; these include specific epidemiology, health outcomes and other observational studies to better understand disease natural history, incidence/prevalence, co-morbidities, treatment patterns, and health and safety outcomes in ‘real world’ patient populations
• Advise on the associated analyses plans using information developed in the execution of the data quality pipelines
• Ensure information is surfaced to ensure the externally sourced data is fit for purpose
• Develop systems, processes and tools (pipelines) which impact enterprise use of our data assets and confirm data quality
• Lead global organizational RWD transparency and education by delivering learning modules on relevant dimensions for users’ qualifications

Technical/Functional (Line) Expertise

• Comprehensive understanding of the pharmaceutical industry and drug development
• Understand and enable analytic infrastructure, including CFR 11 certified software tools, semi-automated, validated SAS algorithms and a skilled data visualization team offer efficient delivery of research and rapid analytics

Leadership

• Demonstrated ability to work across functions, regions and cultures
• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
• Proven skills as an effective team player who can engender credibility and confidence within and outside the company
• Ability to distil complex issues and ideas down to simple comprehensible terms
• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization

Interaction

• Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
• Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
• Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner
• Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions

Innovation

• Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation
• Comfortable challenging the status quo and bringing forward innovative solutions
• Ability to take risks implementing innovative solutions, accelerating time to market
• Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
• Role models respect and inclusion, creating a culture that fosters innovation

Complexity

• Ability to work in a global ecosystem (internal and external) with a high degree of complexity
• Deep expertise required
• Ability to see and understand broader, enterprise level perspective 

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Advanced degree in Computer Science, Data Science, Life Sciences, Epidemiology, Bioinformatics, Clinical Informatics or similar technical fields
• 5-8 years relevant work experience with a focus on clinical, observational or RWE data management ingestion, curation, and analysis
• Experience establishing and managing relationships with external vendors and organizations for the acquisition of observational RWD
• Deep understanding of drug development and biopharmaceutical industry, with emphasis on role of observational RWE data
• Experience using hardware and software used to curate, process and analyze data
• Experience with scripting/coding languages (R, Python, Unix scripting, etc.)
• Knowledge of data analysis and trending and familiarity with statistics
• Experience developing and implementing process and data standards
• Strong project management skills, and ability to effectively lead, collaborate and communicate across diverse group of observational RWE data stakeholders (scientific, technical, operational)
• High attention to detail including proven ability to manage multiple, competing priorities
• Demonstrated ability to establish and manage effective business relationships with internal and external stakeholders