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Clinical Epidemiologist/Senior Epidemiologist

Company: CSL Behring
Location: King Of Prussia
Posted on: May 23, 2020

Job Description:

With operations in 35+ nations and - 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.CSL is the parent company of CSL Behring and Seqirus.CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operatesCSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!ResponsibilitiesThe incumbent will be responsible for leading epidemiological activities for assigned products across therapeutic areas within Clinical Research & Development to facilitate robust, evidence based decision-making. (S)He proactively identifies the need for epidemiology evidence, and develops and executes research strategies that optimize the contribution of epidemiological data across the span of product lifecycle. In collaboration with cross-functional teams, the Epidemiologist also leads structured benefit-risk assessments of assigned products using qualitative and quantitative methods.At CSLB the position is located within the Clinical Epidemiology function of the Global Clinical Safety & Pharmacovigilance (GCSP) department. The role works closely with other groups across the company including Clinical Research and Development and Commercial Development. The role has potential for matrix management, participation in global teams, interactions with regulatory agencies in multiple countries, and presentation and publication of research outcomes.QualificationsAs the lead epidemiologist, actively participate in internal teams and committees and proactively define appropriate strategies to execute epidemiological research. Goal of the strategy is to ensure high quality epidemiology deliverables across the product lifecycle. Plan, coordinate and execute all aspects of epidemiology research programs/studies, including protocol development, data collection, data management, data analysis, report generation. Prepare results for internal decision making, regulatory agency submissions, publications and technical reports.Lead the execution of structured benefit-risk assessments, using qualitative and quantitative methods as appropriate.Contribute to reporting of epidemiological data and study results in routine and ad hoc regulatory submissions documents (e.g., protocols, Product Clinical Development Plans, Risk Management Plans, Risk Evaluation and Mitigation Strategies, Periodic Safety Update Reports, Development Safety Update Reports, responses to Health Authority questions and requests).Plan, coordinate and execute all aspects of contracting and oversight of work conducted by external parties (e.g., CROs, academic investigators).Participate in discussions with internal and external stakeholders, including regulatory agencies and clinical investigators. Explain epidemiologic concepts and present results of epidemiological programs and studies to internal and external stakeholders with varying levels of epidemiologic research knowledge. Take responsibility and initiative to advance own technical skills by critical review of emerging methodological literature and attending relevant scientific/professional society meetings. Present and publish at scientific conferences and peer-reviewed journals. Position Qualifications and Experience Requirements:EducationDoctoral degree in epidemiology or related quantitative discipline preferably with post-doctoral experience in the pharmaceutical industry, regulatory or academic setting, or Contract Research Organizations with a pharmaceutical company customer base.Or, Master's degree in epidemiology or related quantitative discipline with at least 3 years of post-graduate experience in the pharmaceutical industry, regulatory or academic setting, or Contract Research Organizations with a pharmaceutical company customer base.ExperienceDemonstrated ability to independently carry out assigned duties, troubleshoot and identify technical and operational problems in the execution of duties, and to independently pursue solutions to ensure objectives are met efficiently and in a timely manner.Experience with structured benefit-risk assessment methods (both qualitative frameworks and quantitative analysis) is preferred.Experience working successfully in cross-functional teams or in a matrix organizational structure.CompetenciesUnderstanding of and expertise in epidemiologic methods, observational and experimental study designs and analysis.Understanding of qualitative structured benefit-risk assessment methods.Ability to conduct high-quality comprehensive literature reviews and critically interpret epidemiologic data and publications.Fluency in writing epidemiological sections of scientific and regulatory agency documents (e.g., study protocol, study reports, Risk Management Plan).Ability to strategically plan for the optimal, fit for purpose application of epidemiological research in product development and post-marketing support with some supervision.Ability to negotiate scientific and operational decisions with cross-functional teams, external collaborators, regulatory agencies with some supervision.Knowledge of drug or vaccine development process.Ability to independently conduct research projects.Knowledge of the major epidemiologic data sources in the USA and Europe including electronic health records, insurance claims databases. Facility in use of computer systems and data processing software.Strong interpersonal and organizational skills and ability to prioritize individual workload.Strong verbal, written and presentation skills and excellent written and spoken English.Lead and/or represents Clinical Epidemiology at internal CSL Behring strategic initiatives and work groups.CapabilitiesWorker Type:EmployeeWorker Sub Type:Regular

Keywords: CSL Behring, Philadelphia , Clinical Epidemiologist/Senior Epidemiologist, Healthcare , King Of Prussia, Pennsylvania

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