A LITTLE BIT ABOUT FCS

Since 1984, Florida Cancer Specialists & Research Institute & Research Institute (FCS) has built a national reputation for excellence.  With over 250 physicians, 220 nurse practitioners and physician assistants and nearly 100 locations in our network.  Utilizing innovative clinical research, cutting-edge technologies, and advanced treatments, we are committed to providing world-class cancer care.  We are recognized by the American Society of Clinical Oncology (ASCO) with a national Clinical Trials Participation Award, FCS offers patients access to more clinical trials than any private oncology practice in Florida. Our patients have access to ground-breaking therapies, in a community setting, and may participate in national clinical research studies of drugs and treatment protocols. In the past five years, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with FCS participation prior to approval.

Through our partnership with Sarah Cannon, we are one of the largest clinical research organizations in the United States. Often, FCS leads the nation in initiating research studies and offering ground-breaking new therapies to patients.

Come join us today!

SUMMARY:

Under the direction of the Director/Manager of Real-World Evidence (RWE), the Real-World Evidence Analyst will be an important member of the team providing statistical expertise in the design and analysis of real-world studies, as well as the interpretation and reporting of the results. The Real-World Evidence Analyst works with the Informatics Oncology Nurse Curators, Manager of RWE, and Director of RWE to produce results and insights for contracted real-world evidence projects and relay those insights back to the RWE partners and FCS practice. The Real-World Evidence Analyst is expected to thrive in an agile scrum environment being able to multitask and work between competing objectives and deadlines.

The Real-World Evidence Analyst is expected to engage frequently and professionally with the RWE team and outside partners to understand the requirements for running feasibility queries, creating study cohorts, and performing analyses (descriptive and statistical). The Real-World Evidence Analyst will utilize their healthcare data knowledge to assist with refining queries, performing appropriate data validation, and analyses to assess endpoints of interest. The Real-World Evidence Analyst is expected to be able to work independently and utilize critical thinking to identify data discrepancies during data ingestion and validation.

PRIMARY TASKS AND RESPONSIBILITIES:

• Reviewing case report forms, annotated case report forms and database documentation to ensure that the datasets meet study requirements.
• Writing statistical analysis plans (SAPs).
• Creating table and listing shells per the SAP.
• Generating database listings for database QA audits.
• Writing and/or supervising SAS programming and QC to create consistent and validated data sets, tables, figures and listings for clinical study reports.
• Performing sample size calculations and write/review the statistical methodology section for study protocols.
• Performing statistical analyses of data and interpreting results to ensure validity of conclusions.
• Providing final tables, listings and figures for clinical study reports.
• Interacting with the team in the production, review and approval of integrated clinical study reports.
• Participating in departmental infrastructure building; experience developing and implementing programing standards/best practices, developing and maintaining SAS macro and program libraries, and managing/forecasting workload with the ability to prioritize work to support multiple studies.

EDUCATION/CERTIFICATIONS & LICENSES:

• Master’s degree in statistics, public health, epidemiology, or another related field with at least 5 years of experience performing statistical analysis and reporting for HEOR, RWE, or clinical trial studies.
• PhD preferred in statistics, public health, epidemiology, or another related field.

EXPERIENCE:

• SQL and a statistical programming language for data analysis and advanced statistical techniques (e.g., Stata, SAS, R, Python).
• Have a thorough understanding of the requirements of the management and analysis of clinical data as required by GCPs, FDA and ICH guidelines.

CORE COMPETENCIES, KNOWLEDGE/SKILLS/ABILITIES:

• You should possess excellent problem solving, organizational, written and oral communication skills; the ability to manage multiple priorities and attention to detail is critical.
• You must have proficient computer, Microsoft Word and SAS programming skills including experience implementing standards end-to-end are required.
• You must have the ability to perform statistical analyses of clinical data, prepare written interpretations of statistical results and to integrate these findings into clinical study reports and publications.
• Must be able to work with multiple studies and datasets simultaneously with eagerness to learn and thrive in fast-paced, dynamic environment.
• Advanced skills in Excel.

VALUES:

• Patient First – Keeping the patient at the center of everything we do
• Accountability – Taking responsibility for our actions
• Commitment & Care – Upholding FCS vision through every action
• Team – Working together, one team, one mission

Expectations for all Employees

Every FCS employee is expected to regularly conduct themselves in a professional and respectful manner, to comply with all labor laws, workplace policy and workplace practices.  Employees are expected to bring issues of any forms of workplace harassment, discrimination, or other potential improprieties to the attention of their management or the human resources department. 

#LI-YB1

#FCS-IT

SCREENINGS – Background, drug, and nicotine screens

Safeguarding our patients and each other is an important part of how we deliver the best care possible to the communities we serve. All offers of employment at Florida Cancer Specialists & Research Institute are contingent upon clear results of a thorough background screening.  Additionally, as a condition of employment, FCS requires all new hires to receive various vaccinations, including the influenza vaccine, barring an approved exemption. In addition, FCS is a drug-free workplace, and all new hires will be subject to drug/ nicotine testing.

EEOC

Florida Cancer Specialists & Research Institute (FCS) is committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at FCS, please email FCS Recruitment ([email protected]) for further assistance. Please note this email address is intended to request an accommodation as part of the application process. Any other correspondence will not receive a response.

FCS is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.