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Principal Biostatistician,

Expired Job

PRA Health Sciences Blue Bell , PA 19422

Posted 1 month ago

Designs, plans, and executes sound statistical methodology to prepare the statistical components for Data Monitoring Committees (DMCs).

  • Serves as an independent reporting statistician on multiple Data Monitoring Committees (DMCs).

  • Develops DMC Charters.

  • Develops DMC statistical analysis plans and reporting specifications for simple to complex clinical studies.

  • Develops and describes appropriate statistical techniques for the analysis of data in a DMC statistical analysis plan.

  • Consults with other statisticians on statistical methodology, study design, therapeutic area details, and data analysis.

  • Performs statistical analyses and interprets results from simple to complex clinical studies for DMCs.

  • Develops or QCs analysis programs to implement techniques described in the DMC statistical analysis plan.

  • Assesses model assumptions for statistical analyses.

  • Develops and presents statistical summary reports to DMC members.

  • Maintains, develops, and shares knowledge of company and industry procedures and methodologies.

  • Performs billable work in accordance with PRA's policies, procedures, and SOPs.

  • Maintains in-depth knowledge of drug development process.

  • Maintains in-depth knowledge of SAS procedures and good programming practices.

  • Continues statistical training on new methods and techniques via self-study, internal training and courses, and external conferences and courses.

  • Trains and mentors new or junior DMC statisticians on statistical methods and PRA procedures.

  • Participates in sales activities, including bid defense meetings and preparation and review of estimates and proposals.

  • Develops in-depth knowledge of FDA and EMEA guidelines and requirements for reporting of clinical trials data for DMCs.

Qualifications:

  • MS and/or PhD degree in Statistics or Biostatistics

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.


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Principal Biostatistician,

Expired Job

PRA Health Sciences