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  • 3322 West End Avenue
    Nashville, TN 37203

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Senior Statistical Programmer - Work From Home

Sarah Cannon Clinical Operations • Nashville, TN

Posted 22 days ago

Job Snapshot

Full-Time
Healthcare - Health Services
Research, Strategy - Planning, Information Technology
3

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Job Description

SeniorStatistical Programmer – Work From Home
 

Sarah Cannon Development Innovations is a full-service contract research organization (CRO) that is uniquely focused in oncology. Sarah Cannon Innovations offers strong scientific leadership, access to patients through Sarah Cannon Research Institute’s Site Management Organization (SMO) and relationships with other clinical sites, and experience in drug development and delivery of clinical trials from First-In-Man through registration level studies, making us the partner of choice for oncology.

Our differentiator is strong operational delivery in partnership with our Site Management Organization and physician leaders to deliver your program efficiently.

Sarah Cannon Development Innovations works with Sarah Cannon Research Institute strategic and network sites throughout the United States, along with investigators at sites outside of the Sarah Cannon Research Institute network. This reach allows Sarah Cannon Development Innovations to offer sponsors access to a diverse and varied patient population, spanning multiple tumor types and disease stages. These relationships further enhance the depth and breadth of Sarah Cannon Development Innovations’ therapeutic expertise, enabling it to provide focused, strategic operational support. This support ensures that clinical trials are conducted in a timely manner and reported with high-quality, registration-standard data.

Sarah Cannon, the global cancer enterprise 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.

**This is a Work From Home position and you can be located anywhere inthe United States to be eligible for this role.

Summaryof Position:
Thisposition is responsible for statistical programming of Sarah Cannon clinicaltrials data.
 
Duties and Responsibilities
 
Duties include but are not limited to:
  • Create review and/or approve annotated CRF to SDTM datasets
  • Responsible for the translation of the SAP into programming specifications for analysis data model (ADaM) datasets
  • Review and provide input on  key study-related documents produced by other functions, such as case report forms, data management plan, statistical analysis plan and TFL specifications
  • Responsible for the development, review, validation, and execution of SAS programs to generate standard (SDTM and ADaM) and non-standards (custom study specific) datasets as defined in specifications documents
  • Responsible for the development, review, validation, and execution of SAS programs to generate presentation-ready outputs (i.e., Tables, Figures, and Listings), as defined in the statistical analysis plan
  • Write and validate study and product-level macros and utilities
  • Review of statistical output and clinical study reports
  • Program the integration of databases from multiple studies or sources
  • Ensure accuracy, quality, and timeliness of all work completed for the project.
  • Communicate effectively within a multi-disciplinary project team and external resources to complete assigned tasks on time and within budget
  • Responsible for accuracy and reliability of results. Function as study lead programmer on one or more clinical trials:
    • Provide project deliverable oversight, guidance and direction to the programming team.
    • Provide guidance in programming for complex analysis tables/figures, appropriate procedure/method selection for advance statistical analyses
    • Ensure all programming activities on the study adhere to required standards
    • Provide input to and participate in team meetings
    • Work closely with the client and Sarah Cannon project statisticians to ensure that all project milestones are communicated, tracked, and delivered within agreed upon planned timelines
  • Manage project budget and resource requirements
  • Carry out all activities according to Sarah Cannon 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 workload with limited supervision
Competencies
Knowledge:A body of information needed to perform a tasks; May be obtained througheducation, training or experience
  • 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
Skills:The proficiency to perform a certain task
  • Excellent organizational, interpersonal, communication skills and multi-tasking abilities
  • Ability to work in a team environment
Abilities:An underlying, enduring trait useful for performing duties
  • Capable of problem solving.
  • Able to debug and resolve code issues independently
  • Excellent written and oral communication skills
  • Excellent attention to detail and quality-driven
  • Ability to effectively organize and manage multiple assignments with challenging timelines
  • Ability to adapt and adjust to changing priorities
  • Ability to accept direction of lead team members

Job Requirements

Minimum Qualifications
 
Education:
Minimum Required: Master’s Degree(1-2 year program)
Preferred: Master’s Degree (1-2 yearprogram)
 
Experience:
MinimumRequired:
  • 3-5 years of statistical programming in a clinical trial environment(i.e. pharmaceutical, biotechnology, and/or contract research organizationindustries)
  • Experience programming and reporting with Base SAS, SAS/Macro,SAS/STAT, SAS Language, SAS/ODS and SAS/Graph
Preferred:
  • Understanding of FDA/ICH guidelines
  • Experiencewith industry data standards, such as CDISC/SDTM, ADaM data models.
  • Strongknowledge in the creation/production of tables, figures and listings (TFLs)
  • Strongknowledge in developing SDTM and ADaM datasets
  • Oncology experience
 
**Ifinterested in advancing your career with a growing leader in cancer research pleaseapply today!

Job ID: 25319-4628
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