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Orion Group · 1 day ago

Clinical Application Specialist II – Neuroscience Epidemiology

United States

Contract

Remote

Mid, Senior Level

$53/hr - $56/hr

Orion Group is seeking a Clinical Application Specialist II for their Global Epidemiology department within Clinical Sciences. This role involves supporting pharmacoepidemiologic studies, contributing to regulatory submissions, and performing literature reviews related to neuroscience.

Human ResourcesRecruitingStaffing Agency

No H1B

Hiring Manager

Rachael J.

Responsibilities

Conduct literature reviews and data landscaping, including evaluating, synthesizing, and communicating epidemiology literature in both written and presentation formats

Lead and contribute to real-world evidence (RWE) generation, including evidence gap identification, study conceptualization and design, development of protocols and statistical analysis plans, collaboration with analytic teams for high-quality study execution, rigorous interpretation of results, as well as synthesis and dissemination of findings through internal decision materials, cross-functional forums, and external scientific communications

Contribute to product safety and benefit-risk evaluations, including epidemiological safety assessments, development of safety-related analyses, and contribution to risk management plans, benefit-risk assessments, and regulatory safety deliverables

Generate tables, listings, and graphs for compound projects. Generate and review validated table, listings, and graph output meeting the needs of Clinical Projects

Responsible for the validation and quality assurance of any output produced

Qualification

EpidemiologySAS programmingData analysis platformsLiterature reviewsCommunication skillsNeuroscience experienceQuality assuranceCritical thinkingProject management

Required

PhD with experience in the field of epidemiology, outcomes research, or related discipline

SAS program experience required

Must have excellent understanding of epidemiologic data sources, methods, and study design; and a demonstrated ability to apply them to address program needs

Knowledge of public and private real-world data sources including large observational databases

Experience in conducting comprehensive literature reviews to synthesize current research findings and identify gaps in existing knowledge. This includes proficiency in using databases such as PubMed, Embase, and Cochrane Library, as well as expertise in assessing the quality and relevance of scientific articles

Experience with disease state epidemiology (eg, population sizing) globally and regionally using short-term studies/analyses

Understanding of methods for adverse event collection and evaluation, signal detection, and signal validation. Familiar with quality assurance, legal and regulatory functions, database functionalities, and management processes

Knowledgeable of U.S. and international safety regulations and current regulatory safety review processes

Demonstrated experience in managing large studies or projects

Excellent oral and written communication skills

Ability to clearly communicate epidemiology concepts, both verbally and in writing, to diverse audiences

Able to articulate study rationale, design, and expected impact on supported programs

Ability to generate tables, listings, and graphs for compound projects

Responsible for the validation and quality assurance of any output produced