Senior Biostatistics Scientist — Clinical Trials Strategy

MSD; Rahway (NJ); Hybrid; USD 180,000 - 260,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ, is seeking a senior Biostatistics and Research Decision Sciences leader to guide late-stage drug/vaccine projects.

The role directs statistical strategy, trial design, and cross-functional collaboration across Clinical, Regulatory, and Data Management teams to meet global regulatory standards. The successful candidate will have a PhD in statistics or biostatistics (or equivalent) with extensive leadership, a track record in clinical development, and strong

Qualifications

• PhD or equivalent in statistics/biostatistics with a minimum of 9 years relevant work experience, or Master’s degree with a minimum of 12 years relevant work experience.
• Solid knowledge of statistical analysis methodologies and experimental design.
• Strong project management skills.
• Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.

Responsibilities

• Serves as statistical lead in cross-functional project teams.
• Lead, develop, coordinate, and provide biostatistical support for late development statistics projects.
• Coordinate statistical activities for clinical drug/vaccine projects with Clinical, Regulatory, Statistical Programming, Data Management and other teams.
• Lead interactions with external CROs and consultants.
• Develop and oversee study design and analysis plans.
• Mentor junior staff and participate in departmental activities.

Skills

Statistical leadership

Clinical trial design

Project management

Written communication

Team leadership

Regulatory knowledge

Biostatistics

Data analysis

Statistical Programming

Education

PhD in statistics/biostatistics

Master’s in statistics/biostatistics

Tools

SAS

R

Job description

Merck & Co., Inc. in Rahway, NJ, is seeking a senior Biostatistics and Research Decision Sciences leader to guide late-stage drug/vaccine projects.

The role directs statistical strategy, trial design, and cross-functional collaboration across Clinical, Regulatory, and Data Management teams to meet global regulatory standards. The successful candidate will have a PhD in statistics or biostatistics (or equivalent) with extensive leadership, a track record in clinical development, and strong