OVERVIEW:

The organization has undergone recent shifts within its leadership team and has expanded its clinical portfolio over the past year. With multiple programs advancing and a major regulatory submission on the horizon, they are seeking an experienced statistician to support ongoing and upcoming study deliverables.

SCOPE and FUNCTIONS:

• Develop and execute clinical trial simulations using SAS or comparable statistical tools
• Support ongoing data review activities, including data cleaning and contributing to database lock processes at study completion
• Assist in the development of key statistical deliverables such as Statistical Analysis Plans (SAPs), Clinical Study Reports (CSRs), and regulatory submission materials
• Translate complex statistical outputs into clear, decision-ready insights for cross-functional stakeholders without deep statistical backgrounds

SPECIAL REQUIREMENTS:

• PhD in Statistics, Biostatistics, or a closely related field
• Demonstrated depth in statistical methodology and hands-on application within clinical development
• Strong academic foundation from a well-regarded institution with rigorous quantitative training

NOTE: This role is focused on statistical strategy and interpretation — not purely statistical programming.

LOGISTICS:

• Remote, with preference for candidates based in the Northeast U.S.
• Contract duration: approximately 6–12 months
• Expected commitment: 30–40 hours per week