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.
PRINCIPAL DUTIES AND RESPONSIBILITIES:- 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. Receives little instruction on day-to-day work, general instructions on new assignments.
- 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.
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: 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: - Master's degree with at least 8 years' related experience; or a PhD with at least 5 years' related experience.
- Strong SAS programming skills
The rate of pay for this position will depend on the successful candidate's work location and qualifications, including relevant education, work experience, skills, and competencies.
Rate: $117,700 - 196,200
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 and potential for performance-based bonuses depending on company and individual performance
