Director, Biostatistics & Clinical Strategy (Hybrid)

MFS Investments; Boston (MA); Hybrid; USD 204,000 - 306,000; Full time

Job summary

Vertex is a global biotechnology company that advances scientific innovation and improves patient outcomes. We are seeking a Director of Biostatistics to lead complex statistical work for GMDA, guiding study design, analysis, and strategic direction with independence and seniority.

The role includes people management with budget and HR responsibilities. You will author SAPs, TFLs, and data dissemination plans, collaborate across functions, and engage regulators and payers as needed.

Qualifications

• PhD or master's in Statistics or Biostatistics.
• Typically requires 10 years with PhD or 13 years with master's.
• Experience with drug development and regulatory interactions preferred.

Responsibilities

• Directs multiple clinical trials, observational studies, or RWD investigations.
• Manages a team; mentors staff and drives cross-functional collaboration.
• Authors SAPs, TFLs, and DDPs to summarize study data.
• Leads statistical design innovations and SRF discussions.
• Interacts with regulators and external stakeholders as needed.
• Presents to senior review boards and cross-functional teams.

Skills

SAS

R

Drug development statistics

Education

PhD or MS in Statistics/Biostatistics

Job description

Vertex is a global biotechnology company that advances scientific innovation and improves patient outcomes. We are seeking a Director of Biostatistics to lead complex statistical work for GMDA, guiding study design, analysis, and strategic direction with independence and seniority.

The role includes people management with budget and HR responsibilities. You will author SAPs, TFLs, and data dissemination plans, collaborate across functions, and engage regulators and payers as needed.