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Title:Senior Biostatistician
Location:NJ - Northern

Manage biostatistical activities related to drug product development for assigned compounds or indications.

  • Collaborate with internal data management.and/or manage CRO data management and biostatistics.
  • Collaborate with Biostatistics, Clinical and Medical Writing on clinical trial protocols, case report forms, and statistical analysis plans.
  • Provide statistical services in drug development under the direction of statistical management.
  • Provide technical reports for submission to FDA, EMEA or other worldwide regulatory agencies.
  • Colaborate with internal Data Management professionals and manage Data Management and Biostatistical personnel at CROs.

  • M.S. required in Statistics, Biostatistics, Public Health or related field; PhD recommended
  • Three (3) years experience in clinical trials including marketing applications (NDA/BLA) submissions, including FDA and EMEA experience
  • Excellent communication and writing skills
  • Experience with cancer clinical trials preferred
  • Knowledge of FDA, EMEA and ICH guidelines and regulations covering clinical trials, statistics, and data management
  • Knowledge of EDC and CDISC preferred
  • Skilled with SAS or S-Plus

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