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Director, Biostatistics (CNS)
Ref No.: 18-01036
Location: Palo Alto, California
Position Type:Direct Placement
Experience Level: 11 Years
Director, Biostatistics - CNS

The Director, Biostatistics will be functioning as a statistical lead on clinical development projects. This position will work collaboratively with clinicians, data managers, biostatisticians, and statistical programmers in the planning, conduct, and analysis of clinical studies in all phases.

Functions
  • Lead the biostatistics function and personnel to develop and execute statistical strategy, design, and analyses for clinical trials
  • Manage biostatisticians within the therapeutic area.
  • Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results
  • Provide guidelines and standards to CROs to ensure quality of deliverables
  • Work with department head, peer management, and employees to develop, implement, and maintain department standards and practices
  • Help design data capture methods and select appropriate study endpoints for clinical programs
  • Attend meetings with regulatory agencies and support/defend clinical programs
  • Collaborate with researchers and thought leaders in the planning of clinical development programs and the publication of study data
  • Present study results to internal and external audiences
  • Be able to conduct independent research and resolve statistical methodological issues
  • Develop statistical programs as necessary to perform analysis, prepare data displays, verify data accuracy and validity
  • Recruit, develop, and supervise internal and external statistical resources to achieve department functional goals
Requirements
  • PhD in Statistics, Mathematics, or related fields;
  • A minimum of 10 years of experience with at least 3 years of supervisory experience is preferred
  • Good knowledge of drug development regulations pertinent to statistical analysis
  • Experience in contributing to NDAs/BLAs submission and defense is required
  • Proficient SAS programming skills, solid understanding of CDISC models and standards
  • Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills