Principal Epidemiologist, FSP

JOB DESCRIPTION

The Principal Epidemiologist will Leads high-complexity epidemiology, pharmacoepidemiology and RWE workstreams from question framing through protocol/SAP development, collaborating with analysts/programmers/vendors, and delivery of scientifically defensible, client-ready outputs. Serves as a scientific escalation point, maintains clear status/risk visibility, and mentors staff while applying good practice and regulatory expectations for observational evidence.

RESPONSIBILITIES

Responsibilities:

• Lead development of key scientific deliverables, including study concepts, protocols, and SAPs, ensuring scientific rigor and operational feasibility.
• Respond to rapid epidemiological requests, including safety questions and information requests; frame uncertainty and limitations clearly for decision-makers.
• Evaluate and recommend fit-for-purpose real-world datasets (e.g., EHR and medical claims), including relevance, completeness, traceability, and key bias risks.
• When applicable, assess or support use of registries for evidence generation and advise on strengths/limitations for the research question.
• Apply good pharmacoepidemiology practice across planning, conduct, interpretation, and communication of results (including sensitivity analyses and bias minimization).
• Lead/oversee literature review deliverables (rapid or systematic as needed), including development/review of literature search strategies suitable for client release.
• Use recognized reporting/transparency standards for observational studies and routinely collected health data.
• Provide scientific oversight of execution with internal analysts/programmers and/or external vendors; ensure quality review and contribute to inspection/audit readiness.
• Communicate proactively with client and internal stakeholders (e.g., Safety/Regulatory/Clinicians), maintaining clear status updates, risks, and mitigation plans.
• Mentor and coach colleagues on study design, bias minimization, and scientific writing; act as a point of escalation for complex methodological issues.
• Contribute to capability building through reusable templates, best practices, and continuous improvement, consistent with Cytel-style senior scientific roles (attachments assumed as templates).

QUALIFICATIONS

Qualifications / Skills:

• Education: PhD in Epidemiology (or related field) preferred; Master’s is acceptable with significant, directly relevant experience.
• Experience: At least 8 years in pharmacoepidemiology/RWE/observational epidemiology within pharma/biotech/CRO/consultancy/regulator or equivalent applied setting; demonstrated leadership of complex studies.
• Pharmacoepidemiology training preferred, with demonstrated application of good practice principles in planning, conduct, and interpretation.
• Proven authorship and/or final-signoff responsibility for protocols and SAPs (or equivalent analysis plans) for observational/RWE studies.
• Demonstrated experience with multiple real-world data types (at least two of: claims, EHR, registries, linked datasets), including endpoint definition and feasibility assessment.
• Strong working knowledge of pharmacovigilance-oriented evidence needs and safety assessment framing for observational data.
• Advanced scientific writing (protocols, SAPs, reports, manuscripts) and ability to communicate methods and results to senior scientific and non-technical stakeholders.
• Literature review expertise including (e.g, PubMed) proficiency; ability to construct reproducible searches and document search methods when needed.
• Strong stakeholder management, proactive risk communication, and ability to navigate challenging discussions constructively.
• Mentorship capability and track record of elevating team quality/efficiency through coaching and knowledge sharing.