Senior Epidemiologist

Fresenius Medical CareWaltham, MA

About The Position

The Senior Epidemiologist at the Renal Research Institute (RRI) leads epidemiologic data analysis in support of therapies and marketed products within the Fresenius Medical Care (FME) nephrology portfolio. Real-world evidence (RWE) or outcomes research refers to observational studies evaluating the results of medical interventions.

Requirements

  • Strong SAS programming skills
  • Advanced Degree (e.g, MS, MPH, or PhD) or equivalent education/degree in biostatistics or epidemiology required.
  • >5 years related experience with a Master’s degree or >1 years related experience with a Doctoral degree

Nice To Haves

  • 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.

Responsibilities

  • Applies company policies and procedures to resolve complex issues.
  • Conducts 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.
  • Contributes to RWE study design (e.g., observational studies), and objectives for analysis, write analytic programs and ensure quality control conducted on all analyses.
  • 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.
  • Supports IT infrastructure for databases and conduct statistical SAS programming.
  • Defines rigorous statistical and epidemiologic methods in observational research and retrospective data analysis.
  • Appropriately document and track all studies and database projects.
  • Consults as internal advisor on statistics and data analysis as it relates to observational research.
  • 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.
  • Ensures that all deliverables are met according to timelines, budget, operational procedures and quality standards.
  • Support the development of study schedules and budgets.
  • Able to coordinate outsourcing to Contract Research Organization(s) (CROs) and/or other 3rd parties if needed.
  • Other duties as assigned.
  • May provide assistance to other staff with more complex tasks that require a higher level of understanding of functions.
  • May escalate issues to supervisor/manager for resolution, as deemed necessary.
  • Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.

Benefits

  • medical, dental, and vision insurance
  • a 401(k) with company match
  • paid time off
  • parental leave
  • potential for performance-based bonuses depending on company and individual performance
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