September 21, 2016

Director - Biostatistical Services

Confidential Company - Princeton, NJ

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  • Company
    Confidential Company Confidential Company
  • Location
    Princeton, NJ
  • Job Type
  • Job Classification
    Full Time
  • Company Ref #
  • AJE Ref #
  • Number of Positions

Job Description

Our client, a well established international contract research organization serving both commercial as well as government markets, is conducting a search for a Director of Biostatistical Services. . This 'hands-on' leadership position oversees statistical programming team and has the following responsibilities:

* Ensure successful completion of programming (tables, listings and graphs) for statistical deliverables
* Consult/review/write statistical sections of protocols
* Assist in protocol study design (determine sample sizes for all phases of trials )
* Write Statistical Analysis Plans (SAP)
* Review/design CRFs
* Review/write Randomization and Blinding Plans
* Review/write charters for Data Monitoring Committee (DMC)
* Provide SAS code for statistical models
* Validate/perform SAS programming for key data analyses
* Perform quality control on derived variables being analyzed
* Interpret results from analysis
* Maintain documentation
* Review Clinical Study Reports (CSR)
* Provides guidance and direction to team members to ensure departmental and client/project goals are met
* Utilizes metrics to drive and enhance performance
* Coaches, develops and provides continuous feedback to direct reports


* Master's degree in Biostatistics
* 5+ years statistical management experience in a pharmaceutical and/or CRO environment
* Firm knowledge of appropriate statistical methods and statistical analysis plans
* Strong proficiency in SAS and sample size software.
* Experience in Oncology