Bloemfontein, South Africa
1d ago

Who We Are

Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies.

With our mission of Bringing Clinical Trials to Life, we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations.

Our mission is to support the innovation and development of better therapies in healthcare. Position Overview

The Biostatistician plans and conducts the summaries and analyses of data for assigned clinical studies. Works closely with the Sponsor, clinical team, project manager, data manager, other Biostatisticians, and programmers to analyze and present the data based on Sponsor specifications.

Creates, verifies / validates, maintains, and reviews the statistical analysis code and the tables, listings, figures, and analysis outputs for assigned studies in compliance with standard operating procedures and relevant regulatory guidance.

Specific tasks would include :

  • Maintain responsibility for assigned tasks : ensure on-time delivery, communicate the status of tasks to internal teams, provide quality control of work produced by others, and ensure statistical analysis is being done according to specifications.
  • Read and understand the protocol, statistical analysis plan, and other relevant study documentation for assigned studies.
  • Provide sample size calculations and documentation for simple studies.
  • Generate randomization schedules and kit lists.
  • Review case report forms for assigned studies to ensure data is collected appropriately to achieve the analysis defined in the protocol.
  • Contribute to statistical analysis plans and produce mock table and listing shells.
  • Review specifications for derived data sets.
  • Create programming code for inferential analyses, and ensure programming is being done according to Synteract SOPs and Sponsor expectations.
  • Review tables, listings, figures, and analysis output.
  • Perform bibliography research for statistical analysis techniques
  • Degree and Experience :

  • Master's degree or equivalent in statistics, mathematics or related field of study and some related experience or equivalent combination of education and experience.
  • Specific Knowledge :

  • Possesses a basic understanding of statistical methods relevant to clinical trials.
  • Understands the conduct and analysis of clinical trials.
  • Possesses a basic knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
  • Proficiency in BASE SAS or other statistical software is advantageous but not required.
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