Senior Biostatistician

  •  

Philadelphia, PA

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 33 days ago

  by    Jenny Ann Nunez

This job is no longer available.

Title: Senior Biostatistician

Company: CRO

Location: Remote

Type: Permanent Role

Notes: No Corp to Corp

Job Description:

  • Independently providing statistical consulting
  • Preparing statistical sections of protocols, performing sample size and power calculation for studies, and creating randomization schedule per study design and relevant specifications
  • Reviewing protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
  • Independently developing statistical analysis plans (SAP) in accordance with the protocols and SAS programs to develop statistical models and complete statistical analyses
  • Supporting integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
  • Independently preparing analysis data specifications
  • Developing SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
  • Performing quality control of analysis data and TLGs
  • Preparing statistical reports
  • Reviewing, providing input and interpreting of analysis result to clinical study report


Requirements:

  • 4-6 years (or 3-5 years for PhD) direct advance knowledge of clinical trials design and analysis experience with advanced SAS programming experience
  • Working knowledge of CDISC standards and application of those standards to projects
  • Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
  • Detail oriented, well organized
  • Ability to work on several projects simultaneously
  • Demonstrated knowledge of design of clinical trials and regulatory requirements
  • Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
  • Knowledge of design of clinical trials and regulatory requirements
  • Excellent English communication skills (verbal, written & interpersonal)