Manager, Biostatistician (Oncology)

Location: Woodcliff Lake, New Jersey, United States

Contract duration: 12 months

Company

Workforce solutions provider serving customers across multiple industries in the United States and Canada.

What you will do

• Lead statistical support for complex oncology clinical trials and multiple studies.
• Contribute to clinical study design, protocol development, and Clinical Development Plans.
• Develop and review Statistical Analysis Plans, statistical documents, clinical study reports, and integrated efficacy and safety summaries.
• Coordinate with clinical data managers on case report forms, data transfers, edit checks, user acceptance testing, and data quality reviews.
• Oversee SAS programming, quality-control tables, listings, and figures, and perform post-hoc analyses.
• Supervise CROs, support regulatory submissions and publications, and facilitate biostatistics operations and process-improvement initiatives.

Requirements

• MS in Biostatistics or Statistics with at least 5 years of pharmaceutical, CRO, or biotech experience, or PhD with at least 4 years of experience.
• Strong SAS programming skills.
• Required oncology experience.
• Experience with Phase I–III oncology trial design and survival analysis.
• Ability to manage multiple projects, solve problems, and maintain quality under tight deadlines.

Nice to have

• Clinical trial submission experience.

Culture & Benefits

• Work across project teams and collaborate with clinical, regulatory, data management, and external CRO stakeholders.
• Participate in committees and infrastructure initiatives focused on improving standard operating procedures, quality, and efficiency.