Epidemiology Director

Job Overview

Work closely with global clients and other functional groups by providing scientific leadership for real world studies on the full spectrum of study designs and approaches from early clinical development through the post approval stage, which include but are not limited to the natural history of disease, external comparators, and comparative safety and effectiveness of drugs, biologics, and devices. Independently designs complex methodologically sound studies to meet project objectives and stakeholder requirements (e.g., regulatory, payers, etc.). Oversees the design of real world studies, analyses, evaluation and reporting of studies. Provides senior epidemiology oversight (as appropriate).  Manage multiple pharmacoepidemiology studies of varying complexity and ensures on-time and on-budget delivery for clients. Contributes to new business development to maintain and strengthen client base. Leads the development of best practices in epidemiology and observational research and other internal initiatives.

Essential Functions

• Accountable for the scientific integrity of the design and implementation of complex epidemiology/ pharmacoepidemiology methods in real world studies and studies using real world data, including (but not limited to) drug safety and effectiveness studies and other observational or low intervention studies using real world data and/or methodology.
• Serves as project director or partnership lead on client facing or internal projects.
• Leads specific research initiatives as needed.
• Authors protocols, reports and other study documents with independent, critical thinking to ensure quality and completeness of output, oversees timeline for deliverables associated with study reporting.
• Reviews and provides relevant epidemiological input to statistical analysis plans and analysis output.
• Reviews and provides epidemiology input for tasks including CRF/eCRF development, form previews and other ad hoc project tasks (e.g., regulatory responses, slide deck development).
• Independently generates (elevates) scientific content and direction for business development proposals, early engagement opportunities, workshops, and offering development.
• Interacts with clients including attendance at bid defenses and other remote or on-site presentations and discussions.
• Provides senior epidemiology oversight and review work of peers and junior staff in areas including observational study methods, statistical methods, safety and pharmocovigilance, the selection of instruments and clinical measures to achieve objectives, and sources and measures for resource utilization and costing.
• Identifies client-related, budget-related and internal issues that may require attention or escalation
• Review budgets for proposals and monitor budgets for contracted work to assure project completion within scope and budget.
• Uses best efforts to complete work with available budget.
• Contributes to intra- and interdepartmental process improvement to achieve "best practices" and to support effective delivery.
• Represents IQVIA externally through conference presentations.
��� May oversee or conduct statistical analysis as needed.
• Leads client engagements throughout the study process; follow up with client post-delivery to ensure satisfaction and delivering high-value, high-impact studies.
• Remain current on industry, clients, and competitive trends and directions in order to anticipate and identify new business challenges and issues with assigned clients.
• Mentor, coach, and share subject matter expertise with others to help develop individuals and capabilities delivering world-class scientific solutions for clients.
• May be external thought leader to set industry best practices

Qualifications

• Master's Degree Graduate education in epidemiology, pharmacoepidemiology, public health with concentration in epidemiology, pharmacy with concentration in epidemiology or relevant scientific field  and 10 years relevant experience
• Ph.D. with 7 years relevant experience Pref
• Sound methodological training in epidemiology, pharmacoepidemiology, public health with concentration in epidemiology, pharmacy with concentration in epidemiology or related area relevant to observational health research.
• Ability to design, plan and conduct observational studies of comparative effectiveness and safety.
• Excellent oral and written communication skills, medical writing experience beneficial.
• Proven leadership skills.
• Exceptional attention to detail and the ability to effectively prioritize and manage multiple tasks.
• Must be proficient in Word, Excel, PowerPoint and Edge. Ability to read output from SAS, R, or other programming languages
• Ability to establish and maintain effective