Director Biostatistics

Key Responsibilities:

• Lead the full scope of Biostatistics activities for assigned clinical programs or indications.
• Define and execute statistical strategies for clinical trials and regulatory submissions.
• Design clinical studies, including endpoints, estimands, and sample size calculations.

Qualifications:

• PhD in Biostatistics, Statistics, or related field with ~8+ years of industry experience, or MS with ~11+ years.
• Demonstrated experience providing statistical leadership at study or program level.
• Strong experience supporting regulatory submissions (NDA/BLA) and interacting with regulatory authorities.

Core Competencies:

• Strong understanding of clinical development processes and regulatory expectations.
• Ability to lead and influence in a matrixed environment.
• Excellent communication skills; able to translate statistical concepts to non-statistical audiences.

Benefits:

• Medical, dental, vision, time off, and 401K.
• Participation in Mineralys incentive plans based on performance.
• US Salary Range: $200,000 - $230,000.