Statistical Director

2 weeks ago


Reston, Virginia, United States Meet Full time

Biostatistics Leadership Role

(Executive Director Leveling)

Position Overview

The Director of Biostatistics provides strategic leadership and oversight of the biostatistics function to support clinical development programs. This role involves statistical input for drug development planning, including feasibility assessments, study design, statistical methodologies, data interpretation, and regulatory submissions.

Key Responsibilities

  • Provide strategic leadership for the biostatistics function, aligning with senior leadership and program objectives.
  • Build and manage a high-performing biostatistics team while fostering a culture of collaboration, innovation, and excellence.
  • Offer strategic input on product development, including statistical study design, clinical endpoint selection, sample size justification, statistical analysis methodologies, and data interpretation.
  • Lead the development and optimization of biometric processes, focusing on efficiency and quality while adhering to industry best practices.
  • Implement innovative study designs and novel statistical methodologies across various therapeutic areas.
  • Stay updated on advancements in science, medicine, technology, and statistical standards relevant to drug development.
  • Perform additional duties as required.

Qualifications

  • PhD in Statistics/Biostatistics with at least 15 years of clinical development experience in the biotech/pharmaceutical industry.
  • Strong leadership and team management skills.


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