Senior Biostatistical Expert

2 weeks ago


Hyderabad, Telangana, India Parexel Full time

About the Role

The Senior Biostatistical Expert will provide high-level statistical support across all complexity levels of clinical trials, with a strong focus on regulatory impact.

Key Responsibilities

  • Develop and implement trial designs, protocols, and CRF configurations.
  • Lead the production and quality control of randomization, analysis plans, statistical reports, and other supporting documents.
  • Perform sample-size calculations, generate randomization lists, and write statistical methodology sections for study protocols.
  • Collaborate with Data Monitoring Committee (DMC) activities, including charter and analysis plan development.
  • Provide statistical input and support for DMC reviews.
  • Stay up-to-date with regulatory requirements and implications for statistical processing and analysis.
  • Develop and deliver 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 for client meetings, presenting and discussing analysis concepts and study results.

Requirements

  • PhD or MS in Statistics or a related field with at least 6 years of experience.
  • Competency in written and oral English, with local language proficiency.
  • Knowledge of pharmacokinetic data is an advantage.


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