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Principal Biostatistician

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GCE Solutions is a Global Biometrics service provider, and we are looking for an experienced Principal Statistician to join our growing European team. You will be working for a global pharmaceutical client and will need to have experience in leading clinical studies. You will be involved in developing study analysis plans as a team member and lead this effort for selected studies. You will also be expected to develop statistical programs as necessary to perform analyses and prepare data displays.

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
  • 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
  • Proven experience working as a Biostatistician within the pharmaceutical industry
  • Good understanding of clinical data
  • Good understanding of client standards for trial designs, data and output
  • Technically very skilled and able to coordinate tasks
  • Experience in CDISC
  • Good communication skills

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.

Every employee has a personal development and career plan, and due to the growth of the company, the development potential is huge. We also offer an annual performance bonus, and a competitive benefits package.