Senior Biostatistics Lead for Late-Stage Clinical Trials

Merck & Co.; North Wales (Montgomery County); Hybrid; USD 191,000 - 300,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Job summary

Merck & Co., Inc. in Rahway, NJ, USA, a BARDS division of the R&D group, seeks a senior biostatistician to lead statistical activities for drug/vaccine development.

The role involves designing trials, leading teams, and coordinating statistical analyses across regulatory and clinical units. Ideal candidates hold a PhD or equivalent in statistics/biostatistics with extensive experience in phase II–V trials, regulatory interactions, and methodological research.

Qualifications

• Solid knowledge of statistical analysis methodologies and experimental design.
• Strong project management skills.
• Solid knowledge of statistical and data processing software e.g. SAS and/or R.
• Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
• Strong oral and written communication skills. Able to function effectively in a team environment.
• Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
• Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.
• Publications in peer reviewed statistical/medical journals.
• An understanding of biology of disease and drug discovery and development.

Responsibilities

• Serves as statistical lead in project teams.
• Develops, coordinates, and provides biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics.
• Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and our company Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
• May interact with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.
• The incumbent may initially work in a specific disease area such as oncology.
• Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.

Skills

Statistical analysis

Project management

Communication

Regulatory knowledge

Clinical trial design

Education

PhD or equivalent in statistics/biostatistics

Master's with 9+ years experience

Tools

SAS

R

Job description

Merck & Co., Inc. in Rahway, NJ, USA, a BARDS division of the R&D group, seeks a senior biostatistician to lead statistical activities for drug/vaccine development.

The role involves designing trials, leading teams, and coordinating statistical analyses across regulatory and clinical units. Ideal candidates hold a PhD or equivalent in statistics/biostatistics with extensive experience in phase II–V trials, regulatory interactions, and methodological research.