HCA, Hospital Corporation of America Statistical Programmer, Work From Home in Nashville, Tennessee
Sarah Cannon, the global cancer institute of Hospital Corporation of America (HCA), offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom. Sarah Cannon’s cancer programs include individualized patient navigation provided by oncology-trained nurses, more than 900 stem cell transplants performed annually throughout the Sarah Cannon Blood Cancer Network, more than 500 clinical trials, and molecular profiling capabilities. Through its services, Sarah Cannon is providing state-of-the-art cancer care close to home for hundreds of thousands of patients, a number unmatched by any single cancer center.
Summary of Key Responsibilities:
This position is responsible for statistical programming of SCRI clinical trials data.
Duties and Responsibilities:
• Create and review annotated CRF to SDTM datasets
• Responsible for the translation of the SAP into programming specifications for analysis data model (ADaM) datasets
• Create and review study specific documents such as validation plans, risk assessments, as appropriate
• Review key study-related documents produced by other functions, such as case report forms, data management plan, and statistical analysis plan
• Responsible for reviewing the SAP and the TFL specifications, and provide feedback to the statisticians
• Responsible for the development, review, validation, and execution of SAS programs to generate standard (SDTM and ADaM) and non-standards (custom study specific) datasets to be included in reports for submission to regulatory agencies, publications, and other communications as defined in specifications documents
• Responsible for the development, review, validation, and execution of SAS programs to generate presentation-ready output (ie, Tables, Figures, and Listings), to be included in reports for submission to regulatory agencies, publications and other communications as defined in Statistical or Report Analysis Plans
• Program the integration of databases from multiple studies or sources
• Responsible for accuracy and reliability of results. Builds and monitors quality in every aspect of job activities
• Able to access and clarify requirements, provide statistical programming solutions and ensure their efficient implementations under supervision
• Communicates effectively within a multi-disciplinary project team to complete assigned tasks on time and within budget
• Communicates effectively not only within the teams and functional lines but also with external resources
• Assists with other duties as assigned
• Carry out all activities according to SCRI SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP)
• Adapts to changing circumstances, policies, work assignments, and/or team members. Able to multi-task and prioritize between tasks
• Display a positive attitude at all times, promoting and contributing to a good team spirit with a productive and professional environment
• Develop good problem solving skills and a willingness to learn and seek advice from senior staff
• Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement”
• During your employment with SCRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
• Knowledge of one or more programming languages
• Knowledge of relational databases
• Knowledge of statistics and/or clinical drug development process
• Knowledge of statistical computing applications such as Base SAS, SAS/STAT, and SAS Macro Language
• Good organizational, interpersonal, communication skills and multi-tasking abilities.
• Capable of problem solving. Able to debug and resolve issues related to other peoples code and/or system macro code independently
• Excellent written and oral communication skills
• Excellent attention and accuracy with details
• Ability to effectively organize and manage multiple assignments with challenging timelines
• Ability to adapt and adjust to changing priorities
Education:Associate Degree. Bachelor's Degree is preferred.
Type of Experience-
• One to three years of statistical programming in a clinical trial environment (ie, pharmaceutical,
biotechnology, and/or contract research organization industries)
• Experience programming and reporting with Base SAS, SAS/Macro, SAS/STAT, SAS Language, SAS/ODS and SAS/Graph
Type of Experience-
• Understanding of FDA/ICH guidelines
• Experience with industry data standards, such as CDISC/SDTM, ADaM data models.
• Experience with industry data standards such as CDISC.
• Strong knowledge in developing SDTM and SDaM datasets.
• Strong knowledge in the creation/production of tables, figures and listings (TFLs) in clinical reporting for regulatory submission.
Time - Given the type of experience stated above:1-3 yrs.
Appropriate education may be substituted for partial experience.
Title: Statistical Programmer, Work From Home
Location: Tennessee-Nashville-Sarah Cannon Research Institute Clinical Operations
Requisition ID: 25319-3519