Senior Biostatistician

  • IDDI
  • Raleigh, NC 27615, United States
  • Mar 01, 2019
Full time Admin-Clerical Consultant Information Technology Other

Job Description

The Senior Biostatistician collaborates on the design, analysis, interpretation and communication of scientific investigations by creating statistical products focused on data analysis and reporting. The Senior Biostatistician supports the analysis of data gathered during the completion of clinical trials.

Your responsibilities will be to:

  • Coordinate statistical tasks for individual projects
    • Manage team production of deliverables
    • Develop timelines for statistical deliverables
    • Track project hours and budget
    • Assign tasks within project team
  • Act as point of client contact for statistical matters for individual projects
  • Write and review statistical sections of protocol, including sample size calculation
  • Write statistical analysis plans including mock table shells
  • Perform statistical analyses for phase I to IV Clinical trials following the Statistical Analysis Plan (SAP) and/or mock tables.

This involves:

  • Reading the protocol and reviewing the CRFs
  • Writing analysis datasets specifications
  • Programming or validating the analysis datasets
  • Tabulating descriptive statistics using SAS macros
  • Performing inferential statistics using SAS or R
  • Graphical representation using SAS or R
  • Performing quality control of statistical programs
  • Act as Independent Statistician for Data Monitoring Committees
  • Write and review Clinical Study Reports

Your Profile:

  • A Master’s degree in Biostatistics or Statistics
  • Previous experience (at least 5 years) in clinical research, with further experience as a statistical team lead
  • Thorough knowledge of SAS, including understanding of SAS macro language
  • Knowledge of R is a plus
  • Knowledge of CDISC ADaM
  • Experience in Data Monitoring Committees is a plus
  • Sense of organization
  • Accuracy and attention to detail
  • Ability to work independently
  • Good communication skills
  • Ability to solve problems

Our offer:   A unique opportunity to work in an innovative, dynamic and future-oriented company with a strong international environment.