Associate Director, Epidemiology

The Associate Director, Epidemiology is responsible for supporting the Epidemiology function at Alnylam providing expertise, and scientific input to epidemiology and real-world evidence (RWE) activities in support of all clinical development programs and marketed RNAi therapeutics. In this role, you will work closely with Biostatistics, Clinical Research, Global Patient Safety and Risk Management (GPSRM), and Regulatory Affairs to inform clinical development and real-world outcomes and answer product- and disease-area research questions for Alnylam RNAi therapeutics using observational studies and real-world evidence. The Associate Director, Epidemiology sits within the Quantitative Sciences organization and reports to the Senior Director and Head, Epidemiology. Provide a rigorous assessment of the incidence and prevalence of disease targets using literature reviews, database analysis, or extrapolation of estimates. Support regulatory submission activities including authoring epidemiology sections of orphan or breakthrough designation applications and dossiers and provide input to the design of post-marketing commitment studies. Investigate and understand potential safety signals for marketed RNAi therapeutics. Participate in activities with Medical Affairs and Commercial teams to establish real-world data partnerships. Support the development of innovative RWE approaches, techniques, and standards to be used across teams. PhD in Epidemiology or other Quantitative Public Health discipline Experience applying epidemiologic methods in at least one disease area, preferably using pharmacoepidemiologic techniques Ability to deliver complex epidemiological studies in a regulated environment with moderate supervision At least 2 years of experience in the pharmaceutical industry or equivalent experience in an academic or government setting Current knowledge of emerging guidance from various regulatory authorities on the design of observational studies and the use of real-world data to support decision making. Current knowledge and expertise in emerging analytical methodologies, tools and applications to ensure fit-for-purpose and innovative approaches on the use of RWD to address pertinent questions. Effective communication skills both at the lay and technical level to inform stakeholders on the utility of RWE across the product lifecycle and drive use of study/analysis results to support internal and external decisions Ability to succeed in a matrixed environment with multiple stakeholders Ability to successfully manage priorities, resources, and performance targets Knowledge of private and public use datasets for the conduct of epidemiological studies Basic knowledge of regulatory requirements in the pharmaceutical industry Proficient written and communication skills