Sr. Biostatistician

Senior Biostatistician 

Location: Remote 

Contract Length: 6-month contract-to-hire

Overview

A clinical-stage pharmaceutical company has an immediate need for an experienced Senior Biostatistician to join its clinical development team. This role is an urgent backfill supporting a Phase III clinical study and regulatory submission activities.

The ideal candidate will bring strong sponsor-side clinical trial experience, preferably within ophthalmology, and be comfortable operating within a small, fast-paced biotech environment. This individual will play a key role in leading statistical activities for ongoing clinical trials, including study design, analysis, and reporting.

This position requires a highly responsive and collaborative professional who can work effectively with cross-functional teams and remain engaged throughout the workday regardless of time zone.

Responsibilities

• Lead statistical support for Phase III clinical trial, including study design, analysis, and interpretation of results
• Contribute to regulatory submission activities, including NDA-related deliverables
• Provide statistical input into clinical study protocols, including sample size calculations, randomization strategies, and endpoint selection
• Develop and review Statistical Analysis Plans (SAPs)
• Oversee and/or develop statistical programming for tables, listings, and figures (TLFs) for interim and final clinical study reports
• Utilize SAS for statistical programming and analysis
• Ensure compliance with CDISC standards (SDTM, ADaM)
• Collaborate with clinical development, regulatory, data management, and other cross-functional stakeholders
• Provide statistical interpretation of clinical data to support decision-making and regulatory documentation

Qualifications

• PhD in Biostatistics, Statistics, or a related field and 5-8+ years of clinical trial biostatistics within the pharma/biotech industry
• PhD is strongly preferred, though MS candidates with strong relevant experience will be considered
• Experience as a Biostatistics study lead for Phase III clinical studies
• Experience contributing to NDA submissions or regulatory filings
• Ophthalmology therapeutic area experience strongly preferred
• Experience working within small to mid-sized sponsor organizations or small team environments is preferable
• Strong proficiency in SAS programming
• Experience working with CDISC standards (SDTM and ADaM)
• Solid understanding of clinical development phases and regulatory requirements