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Title:Sr. Biostatistician
Salary:Open
Experience:3+
Location:NJ - Bridgewater

Description:
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.

Responsibilities:
  • 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 submissions to FDA, EMEA, or other worldwide regulatory agencies.
  • Collaborate with internal Data Management professionals and manage Data Management and Biostatistical personnel at CRO's.

Requirements:
  • M.S. required in Statistics, Biostatistics, Public Health or related field; PhD recommended
  • 3years 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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