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Fresenius Medical Care North America Evidence-Based Medicine Analyst (Epidemiologist) in Waltham, Massachusetts

Job ID 190005RD

Available Openings 1

PURPOSE AND SCOPE:

The Evidence-based Medicine (EBM) Analyst conducts epidemiologic data analysis in support of therapies and marketed products within the Fresenius Medical Care North America (FMCNA) nephrology portfolio. EBM or outcomes research refers to observational studies evaluating the results of medical interventions.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Applies company policies and procedures to resolve a variety of issues.

  • Receives general work instructions on routine work, detailed instructions on new projects or assignments. Work is reviewed for soundness.

  • Works on problems of moderate 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.

  • Escalates 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.

  • Assist with various projects as assigned by direct supervisor.

  • Coordinates and conducts data analysis for EBM studies/requests coming from EBM 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 EBM 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 FMC Corporate Research and RRI databases, and major registries.

  • Collaborates with FMC Corporate Research and RRI to analyze FMC 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

  • Publication of results

  • 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.

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.

  • Frequent interruptions; changing priorities; long hours occasionally required to complete projects. Handle multiple projects with tight deadlines. Work after hours may be required to complete work tasks and meet deadlines;

  • Travel, when necessary, to potential and/or ongoing investigative sites, as well as Investigator and Advisory meetings or other clinical research meetings / congresses is required. 15% Travel

EDUCATION :

  • Advanced degree (e.g., MS, MPH or PhD) or equivalent education/degree in biostatistics or epidemiology preferred.

  • Desirable: Training in health economics (HE), outcome research (OR), epidemiology, and/or health services research; and/or direct analytics experience at HE&OR or Data Management (DM) vendors as well as Pharma & Medical device companies.

EXPERIENCE AND REQUIRED SKILLS:

  • 0-5 years of experience in data analysis of healthcare, pharma, or health economic data.

  • Experience conducting research directly with managed care organizations is preferred but not required

  • Knowledge of outcome research methods (i.e., observational research principles).

  • Knowledge of data mining and data management

  • SAS programming experience required, additional programming languages preferred

  • Formulate objectives for analysis, tables, programming specifications, ensure quality control conducted on all analyses

  • Experience with data management using efficient SAS programming is required.

  • Utilize internal resources and external databases

  • Must be able to work and support multiple studies simultaneously

  • Ability and experience in working in a matrix system/organization

  • Knowledge of renal therapeutic area is preferred but not required

  • Excellent written and verbal communication skills.

  • Excellent organization and tracking skills.

  • Maintains a pro-active and collaborative approach in managing situations involving both internal and external collaborations. Exercises sound, independent judgment.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

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