Associate Director, Biostatistics - Late-Stage Oncology

Merck & Co.; Basking Ridge (NJ); On-site; USD 175,000 - 263,000; Full time

Job summary

Daiichi Sankyo, Inc. is seeking a senior statistician to lead complex studies, including design, SAP development, CSR input and regulatory interactions. The role guides CRO programmers, ensures data quality with the data manager, and contributes to regulatory submissions worldwide under some supervision.

The position emphasizes statistical leadership across development plans, vendor oversight, and collaboration with study teams to optimize study outcomes and timelines.

Qualifications

• Master's degree in statistics or biostatistics required.
• PhD in statistics or biostatistics preferred.
• 8+ years of relevant experience in the pharmaceutical industry with a master's degree.
• 5+ years of relevant experience in the pharmaceutical industry with a PhD preferred.

Responsibilities

• Lead statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review.
• Act as main statistical contact for the assigned studies and projects.
• Provide guidance to study team on all aspects of statistical activities; collaborate with data manager to ensure high quality data.
• Contribute to Drug Development Strategy to ensure scientifically sound designs that meet regulatory requirements and deliver the predefined product profile.
• Review CRO/vendor proposals and budgets; set expectations on deliverables and timelines to guide CRO biostatisticians and programmers.

Skills

Statistical analysis

Study design

Regulatory submissions

Education

Master's degree in statistics or biostatistics

PhD in statistics or biostatistics

Job description

Daiichi Sankyo, Inc. is seeking a senior statistician to lead complex studies, including design, SAP development, CSR input and regulatory interactions. The role guides CRO programmers, ensures data quality with the data manager, and contributes to regulatory submissions worldwide under some supervision.

The position emphasizes statistical leadership across development plans, vendor oversight, and collaboration with study teams to optimize study outcomes and timelines.