Principal Epidemiologist Job at Fresenius Kidney Care Eupora (Waltham)

Job Description

PURPOSE AND SCOPE: Leads epidemiologic data analysis in support of therapies and marketed products within the Fresenius Medical Care (FME) nephrology portfolio in the Renal Research Institute (RRI). Real world evidence (RWE) or outcomes research refers to observational studies evaluating the results of medical interventions.

Job Responsibility

Leads epidemiologic data analysis in support of therapies and marketed products within the Fresenius Medical Care (FME) nephrology portfolio in the Renal Research Institute (RRI)
Leads data analysis for RWE studies /requests coming from RWE management, Medical department, and colleagues (e.g., Brand team) who are managing the development of new products, marketed products, and new product indications
Acts as a subject matter expert and leads RWE study design (e.g., observational studies) and objectives for analysis, writes analytic programs and ensures quality control conducted on all analyses
Provides external communication of analyses in the form of abstracts, posters or manuscripts and conducts the drafting, Editing and delivery of medical communication in a timely manner and within the project scope
Works on complex issues where analysis of situations or data requires an in-depth review of a variety of factors
Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results
Identifies and uses various data sources including FME Corporate Research and RRI databases, and major registries
Collaborates with FME Corporate Research and RRI to analyze FME and RRI data
Defines rigorous statistical and epidemiologic methods in observational research and retrospective data analysis
Appropriately documents and tracks all studies and database projects
Consults as internal advisor on statistics and data analysis as it relates to observational research
Builds productive working relationships
May provide assistance to other staff with more complex tasks that require a higher level of understanding of functions
Mentor other staff as applicable
May escalate issues to supervisor/manager for resolution, as deemed necessary
Ensures that all deliverables are met according to timelines, budget, operational procedures and quality standards
Develops study schedules and budgets
Coordinates outsourcing to Contract Research Organization(s) (CROs) and/or other 3rd parties if needed
Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations
Other duties as assigned

Requirements

Advanced Degree (e.g., MS, MPH, or PhD) or equivalent education/degree in biostatistics or epidemiology required
Master's degree with at least 8 years' related experience
or a PhD with at least 5 years' related experience
Strong SAS programming skills

Nice to have

Training in health economics, outcomes research, epidemiology, and/or health services research
and/or direct analytics experience at HEOR or Data Management vendors or Pharma and Medical device companies

What we offer

Medical, dental, and vision insurance
401(k) with company match
Paid time off
Parental leave
Potential for performance-based bonuses

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