Contract/Consultant Biostatistician (remote)

A clinical-stage biopharma | Remote (US) Role Summary A clinical-stage biopharma is seeking an experienced Contract Biostatistician around the AD / Director level to support its Phase II and III clinical programs on a remote basis. Reporting to the VP of Biometrics, this is a hands-on role for a seasoned statistician who is comfortable operating independently and delivering high-quality statistical work across multiple studies. The successful candidate will bring strong industry experience, deep expertise in clinical trial methodology, and the ability to engage confidently with cross-functional teams and external stakeholders. Responsibilities:

• Serve as study statistician across assigned Phase II and III trials, providing day-to-day statistical leadership and oversight.
• Author and review key statistical documents including protocol sections, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs).
• Design studies and conduct hands-on statistical analyses, including sample size calculations, endpoint selection, and analysis of clinical data.
• Apply advanced statistical methodologies relevant to clinical trial design, statistical modeling, and data analysis.
• Collaborate cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, and Data Management teams.
• Oversee CRO and vendor statistical deliverables, ensuring outputs are accurate, timely, and compliant with regulatory standards.
• Support regulatory submission activities and respond to statistical queries from health authorities.
• Present and communicate statistical concepts clearly to non-statistical colleagues and stakeholders.

Requirements:

• Advanced degree (PhD or Master's with supplementary experience) in Biostatistics or a closely related field.
• Minimum of 10 years of relevant industry experience in biostatistics within a pharma, biotech, or CRO environment.
• Strong hands-on Phase II and III experience, with the ability to lead studies independently and with minimal supervision.
• Proficiency in SAS; knowledge of R or other statistical programming languages is preferred.
• Good understanding of CDISC standards, including ADaM dataset construction.
• Up-to-date knowledge of advanced statistical methodologies related to clinical trial design, statistical modeling, and data analysis.
• Comfortable working with external CRO and vendor partners and holding them to a high standard.
• Excellent communication skills, with the ability to present and explain statistical concepts clearly to non-statistical audiences.

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