Biostatistician PhD (Full-time or Part-time)
Emmes
Bengaluru, India
5d ago

Primary Purpose

A Biostatistician assists on all activities related to the design and development of study protocols, conducting statistical analysis and reporting study outcomes of clinical trials in accordance to the project requirements and with the help of senior members of the team.

Responsibilities

  • Helps senior members in the preparation of study protocols, randomization plans, generation of randomization schedule etc.
  • Conducts statistical analysis as per SAP, completes programming activities, identifies issues in the clinical study and brings them to the attention of the senior members of the team. (under supervision)
  • Performs Quality Control (QC) of own work independently and Quality Control (QC) of other people‚Äôs work under supervision;
  • Executes assigned tasks with high quality, integrity

  • Provides accurate, effective and timely communication of clinical study and defects to senior members of the team.
  • Assists in the documentation of clinical study report / manuscript through statistical interpretation of study results.
  • Works effectively and collaboratively within biostatistics team
  • Experience

  • Requires a PhD degree Biostatistics, Statistics, or Epidemiology
  • Competent in SAS programming language and / or R.
  • Good understanding of basic design of experiments and classical inference methodologies
  • Expertise in statistical methods and its applications in Clinical Research
  • Expertise in GCP principles and other regulatory standards in Clinical Research OR Working knowledge of Good Practice (GxP), International Council for Harmonization (ICH) requirements, internal processes and external regulations that govern drug development
  • Good Computational Skills and Proficiency in statistical applications (SAS, R)
  • Coordinates & communicates with the internal functional project team on client deliverables
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