Remote Senior Biostatistics Director – Clinical Development

Sumitomo Pharma

Denver (CO)

Remote

USD 166,000 - 207,000

Full time

4 days ago

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Job summary

Sumitomo Pharma America, Inc. is seeking an Associate Director of Biostatistics to serve as the statistical lead for one or more clinical programs.

You will shape development plans, study design, regulatory submissions, and data-driven decisions in collaboration with cross-functional teams. The role requires a PhD in statistics or biostatistics (or MS with substantial relevant experience) and a track record in pharma/biotech clinical development, including CRO oversight and regulatory

Qualifications

PhD in Statistics, Biostatistics, or related field with ≥5 years in pharma/biotech OR MS with ≥8 years.
Significant experience providing statistical leadership for clinical programs and trials.
Experience supporting regulatory interactions; oncology/hematology experience preferred.
Experience overseeing CROs, vendors, or external statistical partners.

Responsibilities

Serve as biostatistics lead for one or more clinical programs; contribute to design and analysis strategies.
Represent Biostatistics in cross-functional teams; integrate statistical considerations into decisions.
Lead regulatory interactions, including briefing documents and responses to questions.
Author/review statistical sections of protocols, SAPs, submissions, and publications.
Provide statistical interpretation of results and support data-driven decisions.
Identify risks and mitigation strategies; oversee external statistics activities and timelines.
Provide mentorship to statisticians and programmers; promote governance and standards.