Biostatistician

Biostatistics Research Triangle Park, North Carolina United States


Description

Premier Research, a mid-size clinical research and consulting organization, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medicines.

Its 1,500 employees, operating in 84 countries across six continents, specialize in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.

Whether it's developing product lifecycle strategies, reducing clinical development cycle times, securing patient access, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.

Our Biostatisticians applies knowledge of statistics to independently provide statistical consulting, assist with study design and protocol development, performs statistical analysis of clinical trials. They will also review project related documents, prepare statistical analysis plans (SAPs) and statistical reports. This individual will develop analysis data specifications, create analysis datasets, Tables, Listings and Graphs (TLG) of clinical trial data using SAS. He or she will also perform quality control of TLGs and derived data sets created by others. Develop and validate SAS programs, micros, and utility tools. Apply advanced programming knowledge to support programming efficiencies.

You'll be accountable for:

  • Drafting (with supervision) statistical sections of protocols, performing sample size and power calculation for studies, and creating randomization schedule per study design and relevant specifications
  • Reviewing case report forms (CRFs), data management plans, data specifications and other related study documents
  • Drafting (with supervision) 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
  • Drafting (with supervision) 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

You'll also be Responsible for:

  • Performing quality control of analysis data and TLGs
  • Reviewing, providing input and interpreting of analysis result to clinical study report

You'll Need this Background to be Considered:

Educational Background:

  • Advanced degree (MS or PhD, or equivalent) in statistics or closely related field

Experience:

  • 2-4 years 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

Personal skills & behaviours:

  • 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)