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Associate Director, Biostatistics

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Location
Irvine, CA
Salary
$130,000 - $145,000
Job Type
Direct Hire
Date
Jul 14, 2017
Job ID
2489621
Top Tier Global Pharmaceutical company is expanding and looking for a new AD, Biostatitics
Must have heavy statistics experience (ideally in a pharmaceutical or biotech environment.
PhD preferred.
Salary 130-145k plus bonus , FULL RELOCATION to Irvine, CA
Additional financial incentives- Short term incentives, Long Term incentives and stock, tuition reimbursement
 
The Associate Director, Biostatistics position can independently lead one or more projects ensuring the proper design, analysis, and presentation of clinical studies while adhering to timelines and departmental quality-control standards. This position interacts with domestic and foreign regulatory agencies for Company R&D projects. The position also monitors budgetary and resource needs, and evaluates, hires, and manages CROs and/or contract biostatisticians.
 
The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Company policies and procedures.
 MUST have prior NDA experience.

Main Areas of Responsibilities
  • Independently lead one or more projects ensuring the proper design, analysis, and presentation of clinical studies while adhering to timelines and departmental quality-control standards. 
  • Incumbent interacts with domestic and foreign regulatory agencies for Company R&D projects.
  • Monitors budgetary and resource needs, and evaluates, hires, and manages CROs and/or contract biostatisticians.
  • Assist statistical science process development as needed to improve the efficiency and standardization
  • Represent Statistical Science and Programming on cross-functional project teams.
Requirements
The following listed requirements need to be met at a minimum level to be considered for the job:
  • PhD level with at least 7 years of experience OR MS level with 9 years in pharmaceutical statistics.
  • Managed a whole typical project(s).
  • Study level statistician for reasonable complex project from study design to CSR.
  • 1-2 NDAs regulatory experience.
Education
  • MS or PhD (preferred) in Statistics, Biostatistics, or related fields.GA1