Senior Statistician
PSI CRO
Bogota, Bogota, Colombia
hace 4 días
Job Description

Senior Statistician is an integral part of our team here at PSI. If you have experience in clinical research, understand SAS programming principles and concepts, and have a good knowledge of statistical methods, apply today!

You will:

  • Lead all biostatistics activities related to clinical trials as responsible project statistician
  • Communicate with project teams, clients and vendors on statistical questions
  • Develop and review statistical sections of protocols, including sample size calculations
  • Develop statistical analysis plans
  • Develop and document analysis database structures (i.e. SAS analysis data set structures)
  • Develop SAS program requirements and specifications
  • SAS programming and program validation
  • Review and QC of statistical deliverables (tables, listings, figures, etc.)
  • Perform statistical analysis and report results
  • Consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products
  • Liaise with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics
  • Participate in bid defense meetings and kick-off meetings
  • Train statisticians and SAS programmers
  • Prepare and deliver presentations at investigators' meetings
  • Address audits findings/recommendations, and follow-up on and resolution of audit findings
  • Participate in the development of guidelines, procedures

Qualifications

  • MSc in Statistics or equivalent
  • Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
  • Knowledge and understanding of the SAS programming language; advanced knowledge of SAS software
  • Ability to apply a range of advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information
  • Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
  • Strong knowledge of CDISC ADaM IG 1.0 or later, define 1-0-0.xml and define 2-0-0.xml specifications
  •  Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
  • Presentation and communication skills


Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

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