Job Location : EU & South Africa
Below are the roles and responsibilities:
Responsibilities:

  • Work on the protocol design with clinical scientists
  • Write statistical analysis plans
  • Help design case report forms to ensure all data points are collected for the tables, figures, and listings and other protocol-specific objectives are met.
  • Experience in submissions, Phase II/III, min 5 years experience
  • Review and approve analysis dataset specifications
  • Produce analysis specified in statistical analysis plan and ad-hoc analysis as requested
  • Coaching and mentoring of Biostatisticians
  • Develop study analysis plans as a team member and lead this effort for selected studies
  • Develop statistical programs as necessary to perform analyses and prepare data displays
  • Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings


Skills and Qualifications:

  • Masters or PhD degree in Statistics
  • Strong knowledge of SAS Base and multiple statistical procedures in SAS
  • ICH-GCP
  • Solid experience working as a Statistician within the pharmaceutical industry
  • Strong verbal and written skills
  • Ability to work on multiple projects, plan, organise and prioritise activities.


GCE Solutions is a global clinical research organization (CRO), founded in 2006 in the US. We assist in clinical development in the pharmaceutical, biotechnology, and medical device industries with various programming, statistical, and consultancy tasks among an array of therapeutic areas and phases. We have offices in the US, Europe and India.