PSI CRO AG logo
PSI CRO AG

The global CRO where clinical trials run on time.

Principal Statistician

PrincipalGeneralFull TimeRemoteLeadTeam 1,001-5,000Since 1996H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

0

Seniority

Lead

Postgraduate DegreeEnglish

Job Description

Principal Statistician

PSI CRO AG

• Contribute to statistical activities related to global clinical trials • Work closely with international teams of statisticians, programmers and data managers • Act as a communication line for project teams, clients, vendors and internal team on statistical questions • Conduct statistical analysis for clinical trials • Develop and review study protocols, statistical analysis plans, analysis dataset specifications according to CDISC ADaM standard and other project-specific documents • Review statistical deliverables such as tables, figures, listings and analysis datasets • Conduct departmental induction course and project-specific training for statisticians and SAS programmers • Prepare for and attend internal and external study audits pertinent to Statistics • Participate in preparation of internal/external audits follow up • Provide input to standard operating procedures and other Quality Systems Documents pertinent to activities of Biostatistics department • Liaise with DM on statistical questions related to data issues • Participate in bid defense and in kick-off meetings • Lead teams of SAS programmers and/or statisticians on the project level

Job Requirements

  • MSc in Statistics or equivalent
  • Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
  • Expert knowledge and understanding of the SAS programming
  • Expert knowledge and understanding of CDISC ADaM standard
  • Expert knowledge and understanding of adaptive designs
  • Expert knowledge and understanding of sample size calculation
  • Expert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
  • Ability to apply 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 presentation and communication skills

Benefits

  • Employees can work remotely

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