Remote Senior Biostatistics Director - Clinical Development

Sumitomo Pharma; Montpelier (VT); Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma America, Inc. seeks an Associate Director, Biostatistics to provide strategic statistical leadership for one or more clinical development programs.

This role designs studies, develops analysis plans, supports regulatory submissions, and guides CROs and teammates across functions. You will mentor statisticians, apply Bayesian and complex trial methods when appropriate, and communicate results to senior leadership in a fast-paced environment.

Qualifications

• PhD or MS with extensive pharma/biotech experience.
• Experience leading clinical development programs and trials.
• Experience supporting regulatory interactions is preferred.
• Oncology/hematology exposure is a plus.

Responsibilities

• Serve as biostatistics lead for one or more programs with strategic input.
• Represent Biostatistics on cross-functional teams and study decisions.
• Lead regulatory interactions and prepare statistical sections of documents.
• Provide statistical interpretation and risk mitigation for decisions.
• Oversee CRO/vendor statistical activities and timelines.
• Mentor statisticians and statistical programmers; apply advanced methods.

Skills

Biostatistics leadership

SAS

R

Clinical trial design

Bayesian methods

Regulatory knowledge

Cross-functional collaboration

Education

PhD in Statistics/Biostatistics

MS in Biostatistics/related field

Tools

SAS

R

CDISC standards

Job description

Sumitomo Pharma America, Inc. seeks an Associate Director, Biostatistics to provide strategic statistical leadership for one or more clinical development programs.

This role designs studies, develops analysis plans, supports regulatory submissions, and guides CROs and teammates across functions. You will mentor statisticians, apply Bayesian and complex trial methods when appropriate, and communicate results to senior leadership in a fast-paced environment.