Associate Director, Epidemiology

Alnylam Pharmaceuticals • Cambridge, MA

1d • Hybrid

About The Position

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.

Requirements

• 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

Responsibilities

• Provide a rigorous assessment of the incidence and prevalence of disease targets using literature reviews, database analysis, or extrapolation of estimates.
• Under minimal supervision, 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.
• Partner with Clinical Research and GPSRM to help interpret and refine potential safety signals during drug development.
• With minimal oversight, partner with Biostatistics and Statistical Programming to implement analyses from natural history & other observational studies to support clinical development and scientific publications, presentations and abstracts.
• Methodological and tactical input into the development of RWD external comparators.
• 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.
• Partner with GPSRM to provide input to the REMS, risk management plans (RMPs), and post-approval safety studies (PASS). With moderate oversight, author epidemiology sections of DSURs and PRBERs. Investigate and understand potential safety signals for marketed RNAi therapeutics.
• Partnering with Biostatistics and Statistical Programming to 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.
• 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.
• Mentor RWE analysts to ensure competence in epidemiologic skills and knowledge

Benefits

• comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match
• Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
• We also offer generous family resources and leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree