Job Description Client Overview A global leader in thehealthcare industry, this organization specializes in leveragingdata, technology, advanced analytics, and expertise to driveprogress in healthcare and human health. They offer solutions thatenhance patient outcomes, improve clinical trial efficiency, andoptimize commercial performance. Their services include datamanagement, consulting, and technology solutions tailored to theneeds of healthcare providers, pharmaceutical companies, and otherstakeholders in the healthcare ecosystem. Job Overview Work closelywith global clients and other functional groups by providingepidemiology leadership for real world studies on the full spectrumof designs and approaches from early clinical development throughthe post approval stage, which include but are not limited to thenatural history of disease, external comparators, and comparativesafety and effectiveness of drugs, biologics, and devices, undersupervision of senior staff. Design methodologically sound studiesto meet project objectives and stakeholder requirements (e.g.,regulatory, payers, etc.). Provide input on the data elements anddesign of eCRFs (when applicable) as well as input and review offeasibility and data landscaping. Conduct and review analyses,evaluate and provide reporting of studies. Assignments range incomplexity from providing input into feasibility to the developmentof study protocols and clinical study reports, ensuring dataquality and scientific rigor across all facets of real worldstudies. May contribute to new business development (asappropriate) to maintain and strengthen client base. EssentialFunctions - Leads design and implementation of epidemiology/pharmacoepidemiology methods in real world studies and studiesusing real world data, including (but not limited to) drug safetyand effectiveness studies and other observational or lowintervention studies using real world data and/or methodology. -Support senior staff on specific research initiatives as needed. -Serves as project lead on smaller projects or in support of projectlead on larger client facing or internal projects. - Authors ofprotocols, reports and other study documents with independent,critical thinking to ensure quality and completeness of output,oversees timeline for deliverables associated with analysis andreporting with input and oversight of senior staff. - Reviews andprovides relevant epidemiological research input to statisticalanalysis plans and analysis output. - Reviews and providesepidemiology input for tasks including CRF/eCRF development, formpreviews and other ad hoc project tasks (e.g., regulatoryresponses, slide deck development). - Interacts with clients withsenior staff involvement as needed. - Identifies client-related,budget-related and internal issues that may require attention orescalation. - Contributes to intra- and interdepartmental processimprovement to achieve "best practices" and to support effectivedelivery and quality of deliverables. - May generate content anddirection for business development proposals on smaller projectswith input and oversight from senior staff. - May oversee orconduct statistical analysis as needed. - May contribute to thedevelopment of high quality proposals for new projects. - Maycontribute to the development of best practices in epidemiology andobservational research and other internal initiatives.Qualifications - Master's Degree Graduate education inepidemiology, pharmacoepidemiology, public health withconcentration in epidemiology, pharmacy with concentration inepidemiology or relevant scientific field and 5 years relevantexperience - Ph.D. with 2 years relevant experience - Soundmethodological training in epidemiology, pharmacoepidemiology,public health with concentration in epidemiology, pharmacy withconcentration in epidemiology or related area relevant toobservational health research. - Ability to design, plan andconduct observational studies of comparative effectiveness andsafety. - Excellent oral and written communication skills, medicalwriting experience beneficial. - Ability to establish and maintaineffective working relationships with coworkers, managers andclients in a global and matrixed environment. - Exceptionalattention to detail and the ability to effectively prioritize andmanage multiple tasks. - Must be proficient in Word, Excel,PowerPoint and Edge. Ability to read outputs from SAS, R or otherprogramming languages. - Must be highly organized andself-motivated with ability to determine and meetobjectives.
