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  • Represent Statistics function in study team meetings.
  • Author and/or provide input on statistical sections of clinical study documents including protocols, electronic case report forms, randomization plans, data transfer specifications, statistical analysis plans, tables, listings, and figures (TLF) shells, SDTM/ADaM specifications, clinical study reports, and other relevant documents.
  • Drive TLF development and TLF reviews with programming and other relevant team members, determine analysis populations, validate key analysis results, and present final analysis results to key stakeholders.
  • May be accountable for five or more concurrent clinical studies.
  • Proficiency in SAS and knowledge of CDISC standards.
  • Strong working knowledge of statistical data analysis and data management principles.
  • Knowledge of clinical trial methodology and study design.
  • General project management skills.
  • Good oral and written communication.
  • Good collaborative skills and ability to work with a cross-functional team.
  • Masters/PhD in Statistics
  • Minimum of 5-7 years recent related clinical experience
  • Experience with different clinical phases
  • Clinical experience in a regulated environment and organization fit are the keys things the manager needs for the team .