PURPOSE AND SCOPE: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.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Applies company policies and procedures to resolve complex issues.
• Receives little instruction on day-to-day work, general instructions on new assignments.
• Works on problems of broad scope where analysis of situation or data requires a review of a variety of factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Builds productive working relationships.
• 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.
• 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.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Up to 20% travel is possible.

SUPERVISION:

• None

EDUCATION:

• Advanced Degree (e.g, MS, MPH, or PhD) or equivalent education/degree in biostatistics or epidemiology required.
• Desirable: 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.

EXPERIENCE AND REQUIRED SKILLS:

• >5 years related experience with a Masters degree or >1 years related experience with a Doctoral degree
• Strong SAS programming skills

The rate of pay for this position will depend on the successful candidates work location and qualifications, including relevant education, work experience, skills, and competencies.

Rate: $105,100 - $175,100 for Waltham, MA area
Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave.