Clinical Data Associate Jobs in Reston, VA (NOW HIRING)

The Associate Director of Real-World Data Science is an expert in analysis and methods, providing leadership within Otsuka's OPDC, reporting to the Data and Analytics team. This position demands expertise in research design, and data analysis, including traditional and AI/ML methodologies, that can be applied to health economics research. A visionary approach to managing and optimizing research Real World Data, platforms, processes, and data systems is desired. The successful candidate will possess advanced skills in health economics research, programming and data analysis, focusing on leveraging large healthcare datasets, including claims, electronic health records (EHR), and clinical trial data, data linking/ tokenization, to support value evidence generation.

The responsibilities for this role include collaborating closely with Value Evidence (VE) team and across therapeutic areas to execute HEOR projects and strategies, encompassing pharmaceuticals, devices, and digital health solutions using traditional as well as novel data sources and methodologies. The Associate Director will support successful execution through robust data analyses, project management, and dissemination of HEOR and real-world evidence, late-stage studies to stakeholders. Additionally, the role is critical in producing high-quality research and data to enhance the scientific understanding and the potential value and real-world impact of Otsuka products for payers, healthcare providers, patients, and caregivers.

Responsiblities include:

• Strategic Leadership: Partner with Value Evidence Strategy to design and lead analytical studies and programming for RWE analysis plans to support value and scientific evidence generation.
• Cross-Functional Collaboration: Work closely with Value Evidence and Global Medical Affairs teams to support value and scientific evidence generation across Otsuka's product portfolio.
• Data Analysis and Innovation: Apply fit for purpose traditional or novel methodologies, including AI/ML methodologies, in data and statistical techniques, stay current with new analytical approaches, and collaborate with subject matter experts to design and deliver medically relevant and scientifically valid projects.
• Protocol Development: Co-lead study protocol development and database query guidelines for internal dataset, overseeing internal analyses to support studies.
• Pharmacoeconomic Support: Serve as the interface to support pharmacoeconomic and real-world data needs across various departments.
• Study Management: Co-lead in the preparation and review of study protocols and reports for internal datasets, including statistical analysis plans, and manage associated vendors as appropriate.
• Data Licensing and Vendor Oversight: Manage department-specific data licensing and platform needs, overseeing vendors and ensuring compliance with licensing terms.
• Database Identification: Identify appropriate databases (US and ex-US) for licensing to address research questions and align with therapeutic area strategy.
• External Partnerships: Participate in establishing external partnerships and work on all scientific aspects of projects involving these partnerships.
• Presentation and Communication: Present analytics for health outcomes projects and information to internal and external groups, including regulatory authorities, key opinion leaders, and at medical and outcomes research conferences.
• Publications: Participate in publication planning and execution, coordinating with Otsuka Scientific Communications personnel and VES.
• Advisory Meetings: Support preparation of medical or payer advisory meetings to solicit feedback on Otsuka products and therapeutic areas.
• Project Execution: Identify and support projects that directly support the economic and quality strategy for Otsuka products.
• Formulary Submissions: Support in the development of product dossiers and other projects to support different aspects of formulary submissions.
• Budget Management: Manage budget resources allocated to assigned projects.
• Education and Awareness: When appropriate, assist in developing educational material for internal and external audience including payer communication field tools.

Qualifications/ Required

Knowledge/ Experience and Skills:

• Experience and Expertise:3-5 years of experience in outcomes research methods and analysis, with strong expertise in non-interventional study designs and statistical analyses.
• Industry Knowledge:Comprehensive understanding of the healthcare industry, including pharmaceutical R&D, clinical research, commercialization, health technology assessment bodies, managed care marketplace, hospital systems, and integrated systems of care.
• Technical Skills:Proficiency in statistical programming (SAS and AWS environment required; R preferred), with experience in ML/AI applications.
• Research and Analytical Skills:Ability to independently develop research hypotheses, study protocols, and statistical analysis plans, with knowledge of epidemiology, economics, psychometrics, and medical writing.
• Data Utilization:Strong understanding of administrative claims data, electronic medical records, hospital inpatient data, and survey data, including their applications and limitations.
• Project Management:Proven ability to manage complex projects involving multiple external vendors, with excellent project management skills.
• Interpersonal and Communication Skills:Excellent interpersonal skills, superior presentation skills, and the ability to manage conflict constructively with minimal supervision.
• Stakeholder Engagement:Experience working with and overseeing external contractors and vendors, with the ability to understand and respond to customer/payer requests and develop value dossier
• Travel Requirements:Willingness to travel approximately 10%, including international travel, for conferences, corporate locations, and stakeholder meetings.

Educational Qualifications:

• PhD or Masters in Health Economics, Outcomes Research, Health Services Research, Public Health or related discipline
• Three (PhD) to five (Masters) years of relevant experience

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication -Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings;https://www.otsuka-us.com/careers-join-otsuka.

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