Associate Director, Biostatistics

Woodcliff Lake, NJ

Post Date: 02/20/17 Job ID: 280628-0 Category: Pharmaceutical Salary: $160,000 to $175,000
Title: Associate Director, Biostatistics
Location: New Jersey
Salary: $160,000 to $175,000

Will act as lead biostatistician for clinical studies and projects and be accountable for all statistics related activities for Clinical studies.
Responsibilities:
"Review of protocols for study requirements and design study elements
"Development of statistical documents for multiple clinical trials
"Development of the Study Quality Surveillance Plan and monitoring study conduct
"Provide statistical and validation support
"Lead Preparation of regulatory documents
"Lead project team activities to identify biostatistics issues and provide Biostatistics support to clinical areas
"Develop and maintain work guidelines and other related technical documents
Qualifications:
"PhD in Biostatistics or Statistics with 5+ years clinical trial experience
"Experience with Phase II & III clinical trials with participation in NDA submission activities
"Strong Programming skills in SAS as well as other statistical software
"Knowledge of FDA & EMA guidance for drug development
"Familiarity with the SDTM, ADaM, eSUB standards and requirements
"Excellent communication skills with the ability to handle time sensitive and multiple projects

Nikki Quist
Executive Recruiter

Nikki concentrates her efforts on the nationwide placement of biostatisticians. Building relationships is her highest priority, allowing her to help candidates identify the career goal that best suits them, and help clients align their needs with the marketplace.
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