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Principal Biostatistician

Principal Biostatistician

ParexelBengaluru, India
30+ days ago
Job description

When our values align, there's no limit to what we can achieve.

Job Purpose :

The Principal Biostatistician works independently on all level complexity clinical trial projects, often with major regulatory impact. The person will be recognized internally and externally as a statistical expert.

Operational Execution

  • Provide broad statistical support, including trial design, protocol and CRF development on specific studies
  • Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
  • Perform sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols
  • Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans
  • Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review

General Activities

  • Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis .
  • Understand, apply and provide training in extremely advanced and sometimes novel statistical methods
  • Contribute to the development and delivery of internal and external statistical training seminars and courses
  • Review position papers based on current good statistical practice
  • Interact with clients and regulatory authorities
  • Review publications and clinical study reports
  • Travel to, attend and actively contribute to all kind of client meetings as appropriate (Ee discussing analysis concepts, presenting and discussing study results)
  • Additional responsibilities as defined by supervisor / manager.

    • Knowledge and Experience :

  • PhD or MS in Statistics or related discipline with substantial experience around 6+ Years
  • The knowledge of pharmacokinetic data is an advantage
  • Competent in written and oral English in addition to local language

    • Education :

  • PhD in Statistics or related discipline, MS in Statistics or related discipline