Associate Director, Biostatistics

Employer Industry: Pharmaceutical Industry

• Salary up to $, plus incentive opportunities
• Comprehensive benefits package including medical, dental, vision, and prescription drug coverage
• Generous 401(k) match and tuition reimbursement
• Flexible time off and paid leave programs
• Opportunity to work in a hybrid environment with remote arrangements available
• Chance to contribute to innovative drug development and impactful research

• Provide statistical analysis plans, including study design, sample size, and statistical methods in protocol development
• Collaborate as a core team member on clinical trial conduct, including CRF review and DMC setup
• Develop Statistical Analysis Plans (SAP) and mock TFLs for analyses
• Support regulatory interactions and provide statistical input for FDA meeting briefing packages
• Lead biostatistical tasks for assigned therapeutic areas and manage statistical tasks for clinical projects

• 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 the U.S. and EU
• Strong computer skills with proficiency in Microsoft Office Suite

#Pharmaceutical Industry #Biostatistics #Career Opportunity #Competitive Pay #Healthcare Innovation

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