Associate Director, Epidemiologist

We are recruiting in Europe for a Senior Epidemiologist, who performs as an individual contributor in epidemiology engagements and Real-World Studies. The Senior Epidemiologist owns the development of epidemiology content in study protocols and study reports, under moderate senior guidance. The Senior Epidemiologist also reviews and comments on deliverables (or parts of deliverables) that are authored by others, including feasibility assessments, study protocols, statistical analysis plans, analysis outputs, and study reports. In project delivery, the Senior Epidemiologist effectively communicates Epidemiological aspects internally and externally, including in Sponsor meetings. The Senior Epidemiologist also provides support in business development, including providing epidemiology content for proposals and bid-pursuit meetings, under senior guidance.   

Key Accountabilities:

Accountability

Supporting Activities

Epidemiologic deliverables

• Independently author deliverables for Epidemiological Real-World Studies, including study protocols and study reports, under moderate senior guidance
• Collaborate with medical writers to complete deliverables, such as study protocols, study reports, manuscripts and conference contributions
• Review and comment on deliverables with Epidemiological content, including feasibility assessments, study protocols, CRFs, statistical analysis plans, data applications and data extraction documentation, analysis outputs, and study reports
• Effectively communicate Epidemiological aspects of studies internally and externally, including in Sponsor meetings
• Contribute to the selection of appropriate secondary-data sources, and epidemiology methods and analyses
• Perform comprehensive literature reviews to inform the development and review of reports, including orphan drug applications and risk management plans
• May contribute to study-design workshops for Epidemiological Real-World Studies, including preparation of the material for the workshop and summarizing the outcome of the workshop

Business-development support

• Participate in proposal development, under senior guidance, by applying epidemiological expertise to the optimal design of Real-World Studies (and other studies, as appropriate), addressing key Epidemiologic questions around study / protocol design, epidemiologic-service models and others as appropriate, and by estimating the budget for the work of epidemiologists
• Contribute to development of responses to the epidemiologic and risk- management components of Requests for Proposals (RFPs) and Requests for Information (RFIs)

Cross-functional team support

• Contribute to supporting Parexel teams and staff in obtaining an appropriate level of understanding regarding sound Epidemiologic (and risk management, where applicable) principles, under senior guidance
• Maintain a positive, results-oriented work environment while building partnerships through teamwork and communicating in an open, balanced and objective manner
• May participate in developing internal processes as well as developing and delivering training courses and materials concerning Epidemiology in Real-World Studies, under senior guidance

Thought leadership

• May participate in developing and maintaining Parexel’s industry and collaborator network, as agreed with upper management
• May contribute to selected parts of Parexel’s Thought Leadership contributions, e.g. presentations, articles, posters, as agreed with upper management

Skills:

• Basic understanding of the role of Epidemiology and Real-World Evidence applications in biopharmaceutical industry
• Demonstrated ability to apply Epidemiology skill in project delivery, in academia, biopharmaceutical industry, or elsewhere
• Demonstrated ability present Epidemiology and other scientific ideas in English in the form of scientific publications and/or presentations
• Driven to deliver high-quality results on time and in a highly ethical and professional manner
• Ability to create a sense of urgency and take a proactive, solutions-based approach
• Good interpersonal skills and the ability sustain positive relationships within internal teams and with customers
• Excellent written communication skills in English, and good verbal communication skills in English
• Demonstrated ability work as part of a team
• Comfortable operating in a demanding, fast-paced environment and capable of reacting swiftly to changing business demands
• Demonstrated ability to digest information in a timely manner, assess it critically and provide thoughtful interpretations for timely project delivery, including in study protocols and reports 

Knowledge and Experience:

• 5+ years’ Epidemiology experience, in academia, CROs, biopharmaceutical industry or elsewhere
• Demonstrated ability to apply epidemiologic knowledge to the conceptualization, design, and successful delivery of Epidemiological studies
• Knowledge of key epidemiology study designs (e.g., prospective and retrospective comparative cohort studies)
• Experience in applying epidemiologic / non-interventional research methodologies
• Prior experience of pharmacoepidemiologic statistical-analysis models a plus
• Knowledge of regulations regarding pharmacovigilance, risk management and safety reporting and drug development a plus
• Experience in using different types of data sources across different global regions a plus
• Experience in working in CRO or biopharmaceutical industry settings a plus
• Experience in or knowledge coding in SAS, R or other program(s) a plus

Education:

• Advanced degree (i.e., MD/MPH, PhD, DrPH) in epidemiology or comparable field