Associate Director, Epidemiology

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.

Summary of

Key Responsibilities:

• Provide a rigorous assessment of the incidence and prevalence of disease targets using literature reviews, database analysis, or extrapolation of estimates.
• Guide and advise clinical development study teams on the design and collection of natural history data to better understand disease progression including risk factors and optimal endpoints for use in clinical trials.
• Use real-world and clinical data to refine population size and characteristics for disease targets as clinical development progresses, in both rare disease and prevalent disease areas.
• Help interpret and refine potential safety signals during drug development.
• Implement analyses from natural history & other observational studies to support clinical development and scientific publications, presentations and abstracts.
• Author epidemiology sections of DSURs and PRBERs.
• Investigate and understand potential safety signals for marketed RNAi therapeutics.
• Implement, provide input into the analyses from registries, post-approval safety studies and other observational studies to support regulatory requirements and scientific publications, presentations and abstracts.
• Establish real-world data partnerships.
• Develop innovative RWE approaches, techniques, and standards to be used across teams.
• Mentor RWE analysts to ensure competence in epidemiologic skills and knowledge.

Qualifications:

• 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

U.S. Pay Range $ - $

About Alnylam:
We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people.

We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law.

Alnylam is an E-Verify Employer.