Clinical Application Specialist II

This contractor position will provide support to the Global Epidemiology department within Clinical Sciences at Client and work directly with the Neuroscience therapeutic area (TA) strategy team. The contractor will contribute to the design and execution of pharmacoepidemiologic studies, support characterization of descriptive epidemiology for diseases and indications, contribute to regulatory submissions and responses, and perform literature reviews on topics required for ongoing support and/or development of drugs and devices.

The role requires strong quantitative and critical-thinking skills, fluency in epidemiologic methods and observational data sources, and the ability to work independently in a fast-moving, strategy-driven environment while maintaining scientific rigor and clear documentation.

• 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.

• PhD with experience in the field of epidemiology, outcomes research, or related discipline
• 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 Pub Med, 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.
• Prefer candidate with experience in SAS, R, Aetion, or other data analytic platform
• Preference given to individuals with industry experience
• Experience in the Neuroscience therapeutic area ideal but not required.
• Generate tables, listings, and graphs for compound projects. Responsible for the validation and quality assurance of any output produced. Generate and review validated table, listings, and graph output meeting the needs of Clinical Projects. Prefer candidate with clinical experience. SAS program experience required.

3-5 Years

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.