The Role

In this role, you will utilize your statistical and programming expertise in support of clinical trial programs, regulatory filings, and real world evidence studies. You will be responsible for development of statistical analysis plans and analysis of study data to support regulatory submissions and product commercialization and reimbursement. You will contribute to protocol development, study design and dissemination of findings. You are a self starter who requires minimum supervision and thrives in a fast paced environment.

Responsibilities

• Provide input into the design and execution of studies for regulatory submissions and for reimbursement and commercialization. 
• Provide statistical input into clinical study documents (protocol, case report forms, etc.). 
• Oversee CRO data management and statistical analysis activities.
• Develop statistical analysis plans and clinical study reports.
• Perform statistical programming of deliverables for regulatory submissions, including specification and delivery of integrated databases, outputs and response to regulatory questions.
  • TMF trial documentation.
  • SAS programs and specifications to generate regulatory compliant deliverables 
  • Validation and documentation of SAS programs, CDISC data sets and regulatory output 
  • Produce and validate Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE)
• Develop SAS macros, templates and utilities for data reporting and visualization.
• Develop validated SAS programs to generate tables, listings, and figures (TLFs) for clinical study reports and analysis datasets.
• Follow best practices in programming documentation.
• Conduct analyses for conference presentations and manuscripts. 
• Develop and maintain SOPs and WIs governing statistical analysis, reporting and data management.