Senior Biostatistician

4 weeks ago

Hyderabad, Telangana, India Parexel Full time

Overview


Parexel is seeking a skilled Principal Biostatistician to join our team.


About the Role



  • Work independently on clinical trial projects with varying levels of complexity, often with significant regulatory implications.
  • Provide broad statistical support, including trial design, protocol, and CRF development for specific studies.
  • Lead the production and quality control of randomization, analysis plans, statistical reports, and other process-supporting documents.
  • Perform sample-size calculations, generate randomization lists, and write statistical methodology sections for inclusion in study protocols.
  • Support Data Monitoring Committee (DMC) activities, including developing DMC charters and analysis plans.
  • Collaborate with clients and regulatory authorities.

Responsibilities



  • Understand and apply regulatory requirements related to therapeutic areas and their implications for statistical processing and analysis.
  • Contribute to the development and delivery of internal and external statistical training seminars and courses.
  • Review position papers based on current good statistical practice.
  • Travel to, attend, and contribute to client meetings as appropriate.
  • Additional responsibilities as defined by supervisor/manager.

Requirements



  • PhD or MS in Statistics or a related field with substantial experience (7+ years).
  • Competent in written and oral English in addition to local language.
  • Knowledge of pharmacokinetic data is an advantage.

About Parexel


Parexel is a leading global biopharmaceutical services organization.


Additional Information


Please note that this job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the role.


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