Lead Biostatistician - Late-Stage Clinical Development

Merck; Rahway (NJ); Hybrid; USD 191,000 - 300,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Benefits package

Job summary

Merck is seeking a senior biostatisticist to lead statistical activities in late-stage development and coordinate across Clinical, Regulatory, and Data Management teams. You will design analyses, develop protocols, and ensure regulatory alignment for trials in oncology and other areas.

The role requires PhD or equivalent with extensive experience in statistics, SAS/R, and a strong track record in clinical trial development and regulatory interactions.

Qualifications

• PhD or equivalent in statistics/biostatistics or related field with 6+ years experience (PhD) or 9+ years (Master).
• Strong knowledge of statistical methodologies and experimental design.
• Experience with regulatory expectations for global trials (II–V).

Responsibilities

• Serve as statistical lead in cross-functional project teams.
• Provide leadership and support for late-development drug/vaccine projects.
• Interact with Clinical, Regulatory, Data Management and other teams to design and analyze trials.
• May interact with CROs or external statisticians.
• Mentor junior staff and guide statistical programming teams.

Skills

Statistical methods

Experimental design

Project management

SAS

R

Regulatory experience

Clinical trials

Communication

Learning & detail orientation

Education

PhD in statistics/biostatistics

Master's degree with 9+ years experience

Tools

SAS

R

Job description

Merck is seeking a senior biostatisticist to lead statistical activities in late-stage development and coordinate across Clinical, Regulatory, and Data Management teams. You will design analyses, develop protocols, and ensure regulatory alignment for trials in oncology and other areas.

The role requires PhD or equivalent with extensive experience in statistics, SAS/R, and a strong track record in clinical trial development and regulatory interactions.