Associate Director, Biostatistics

Employer Industry: Pharmaceutical Company

• Salary up to $, plus incentive opportunities
• Comprehensive benefits package including medical, dental, vision, and prescription drug coverage
• Generous 401(k) match and tuition reimbursement programs
• Flexible time off and paid leave programs
• Opportunity for career advancement and professional development
• Hybrid work policy with the possibility of remote arrangements

• Provide statistical analysis plans, including study design and statistical methods in protocol development
• Collaborate with core study/project teams to provide statistical input during clinical trial conduct
• Develop Statistical Analysis Plans (SAP) and mock TFLs for analyses
• Participate in strategic planning for regulatory interactions and prepare documentation for FDA meetings
• Lead biostatistical tasks for designated therapeutic areas and manage supporting statisticians

• PhD or Master’s degree in Statistics or Biostatistics
• Minimum of 7 years (PhD) or 9 years (Master’s) of experience in the pharmaceutical industry
• Strong knowledge of U.S. regulatory requirements and NDA preparation for submissions
• In-depth knowledge of statistical principles and SAS/R programming software
• Effective communication skills with stakeholders across various functional areas

• Experience in the CNS area is a plus
• Familiarity with regulatory submission processes in both the U.S. and EU
• Demonstrated ability to influence and communicate effectively at all levels

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