Director - Biostatistical Services 9/3/2016

Confidential Company Princeton, NJ

Company
Confidential Company
Job Classification
Full Time
Company Ref #
28672984
AJE Ref #
576086827
Location
Princeton, NJ
Job Type
Regular

JOB DESCRIPTION

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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

Qualifications:

* 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