Associate Director, Biostats

Why consider this job opportunity:

• Salary up to $
• Opportunity for career advancement and growth within the organization
• Comprehensive health benefits, including medical, dental, and vision insurance
• 401(k) plan with a 100% match on the first 6% of contributions
• Flexible work environment with options for remote work
• Generous paid time off, including vacation, sick leave, and parental leave

• Act as the lead statistician and main point of contact for designated compounds/indications
• Provide statistical input to overall strategy and trial design within the Clinical Development Team
• Engage with regulatory authorities for discussions at both compound and trial levels
• Ensure consistency in statistical methods and data handling across trials
• Drive the development and communication of integrated analysis to support decision-making and regulatory submissions

• Master's or Ph.D. in a statistical discipline
• Minimum of 8 years of experience in a relevant area or demonstrated capability
• Proven experience in statistical analysis, modeling, and adaptive trial designs
• Familiarity with FDA, EMA, and ICH guidance for drug development
• Experience with regulatory submissions, including BLAs, and knowledge of CDISC requirements

• Experience with drug development in biologics, targeted therapies, and companion diagnostics
• Proven performance in a comparable role, managing multiple complex projects/studies
• Previous experience working with SDTM, ADaM, and eSUB for regulatory submissions

#Biotechnology #Clinical Development #Statistical Analysis #Career Growth #Remote Work

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