Remote Associate Director, Biostatistics – Clinical Lead

Sumitomo Pharma; Hartford (CT); Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma America (SMPA) is seeking an Associate Director, Biostatistics to lead statistical strategy across clinical development programs. You will design studies, analyze data, and interact with regulatory authorities to support submissions.

The role emphasizes strategic leadership, collaboration with cross-functional teams, and mentorship of statisticians in a fast-paced environment, with remote work options and regular on-site meetings.

Qualifications

• PhD in Statistics/Biostatistics with at least 5 years in pharma/biotech.
• Significant experience providing statistical leadership for clinical development programs.
• Experience supporting regulatory interactions and marketing applications is preferred.

Responsibilities

• Lead statistical input for development plans and trial design decisions.
• Represent Biostatistics on cross-functional teams and regulatory interactions.
• Oversee CROs and external statistical vendors to ensure timely outputs.
• Mentor statisticians and statistical programmers within the team.

Skills

Statistical leadership

SAS

R

Regulatory knowledge

Communication

Mentorship

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Tools

SAS

R

Job description

Sumitomo Pharma America (SMPA) is seeking an Associate Director, Biostatistics to lead statistical strategy across clinical development programs. You will design studies, analyze data, and interact with regulatory authorities to support submissions.

The role emphasizes strategic leadership, collaboration with cross-functional teams, and mentorship of statisticians in a fast-paced environment, with remote work options and regular on-site meetings.