Director Real World Evidence (BE)
Boston, MA - Pharmaceutical & Biotech - Hybrid
Date Posted: 10/19/2022 1:15:35 PM
Director Real World Evidence - Boston, MA (Hybrid)
Develop strategic plans to generate real-world evidence according to the development stage of the assigned products. Design and conduct observational studies using either primary or secondary data. Develop study analysis plans based on study concepts and database specifications. Perform statistical analyses, as needed, with good documentation and good quality. Evaluate and identify fit-for-purpose healthcare databases and/or suitable vendors in different countries for projects. Supervise and evaluate the analyses performed by analysts or vendors to ensure the accuracy and efficiency of deliverables. Perform or guide targeted or systematic literature reviews. Contribute to the development of clinical trial protocols, value dossier and forecast. Provide epidemiologic support and input into risk management plans and Periodic Safety Update Reports and safety evaluations. Author study reports or publications (e.g. scientific manuscripts, abstracts, posters, internal and external presentations) and makes presentations to support the product before and after its regulatory approval. Oversee and assist the operational process of observational studies that collect the data from the study sites by tracking the project activities (for example study contract, IRB, monitoring, and site communication). Provides necessary input into project team budget planning; may have budget oversight for specific epidemiology activities. Responsible for managing analysts and/or vendor relations. Responsible for developing and executing RWE strategies for the assigned products. Lead the RWE study team. Will have decision making autonomy for activities that support assigned products. Will be responsible for managing contracts and deliverables with vendors.
PhD in Epidemiology or related field. Minimum of 3 years’ relevant experience as an epidemiologist in generating RWE to support pharmaceutical product life cycles in the biotech or pharmaceutical industry. The role requires strong scientific leadership, strategic thinking, and operational efficiency to support building strong capability in RWE and Epidemiology. Demonstrated creativity, complex data mining capabilities, and solution driven aptitude are necessary capabilities for the role. Strong knowledge of epidemiological study designs, including understanding of observational and epidemiological endpoints and assessments. Strong statistical background. Good knowledge of drug development and life-cycle management. Good knowledge of the current RWD/RWE trend and relevant RWD/RWE guidance and frameworks. Ability to pro-actively identify opportunities and needs for RWE for assigned products. Good statistical programming skills using recognized statistical software packages (e.g., R, SAS, STATA, Python) and understanding of efficient programming with large databases. Knowledge and experience using large medical records or health claims databases. Good written and verbal communication skills. Experience in communicating with all levels of personnel across various departments, in domestic and international environments. Good project management skills including experience in managing multiple tasks concurrently.
Please contact Bill Emker at firstname.lastname@example.org