Senior Director, Biostatistics

2 months, 1 week ago
Full-time
Lead
Data Science and Analytics
Pharmaceuticals
51-250
Founded 2018
$725M raised

Description

  • Provide oversight and input into statistics strategy, planning, execution, and communication for assigned programs.
  • Deliver statistical input into clinical development plans, protocol development, statistical analysis plans, and regulatory submissions.
  • Interpret statistical analysis results and support other product-related initiatives.
  • Collaborate with internal clinical teams and external stakeholders, including Medical Directors and Regulatory partners.
  • Ensure study-level and project-level statistical activities comply with regulatory requirements and company standards.
  • Identify and apply innovative statistical methodologies to improve clinical development efficiency and decision-making.
  • Manage indication and study biostatisticians.

Requirements

  • PhD in Statistics, Biostatistics, Mathematics, or a related field.
  • 12+ years of experience in biotechnology, pharmaceutical, or a health-related area.
  • Knowledge of relevant Health Authority and ICH guidelines and regulations.
  • Demonstrated experience engaging with Health Authorities.
  • Comprehensive understanding of drug development from Phase 2 through launch.
  • Ability to collaborate effectively with diverse stakeholders.
  • Strong written and oral communication skills with attention to detail.
  • Desire to work in a fast-paced, innovative environment.
  • Natural collaborator who enjoys working on a cross-functional team.
  • Domestic or international travel required at less than 10%.

Benefits

  • Salary range of $270,000 to $310,000 USD.
  • Equity and other forms of compensation may be included in the total package.
  • Medical, dental, and vision coverage.
  • 401(k) benefits.
  • Unlimited paid time off.
  • Parental leave.
  • Remote-based work environment.

Interested in this position?

Apply directly on the company website

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