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Sr. Biostatistician

Durham, NC

Posted: 03/18/2019 Employment Type: Direct Hire Job Category: Clinical: Biometrics Job Number: 2282

The person in this role 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.

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

REQUIREMENTS / QUALIFICATIONS:

 
  • Advanced degree (MS or PhD, or equivalent) in statistics or closely related field
  • 2-4 years (4-6 for Senior Biostatistician) 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)

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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