Senior Biostatistics Leader for Trials & Regulatory

Merck & Co.; Rahway (NJ); Hybrid; USD 210,000 - 331,000; Full time

Job summary

Merck & Co. in Rahway, NJ, seeks a senior biostatistician to serve as statistical lead on drug/vaccine development programs. You will design analyses, lead cross-functional teams, and interact with Clinical, Regulatory, and external partners to ensure robust study outcomes.

You will mentor statisticians, drive methodological advances, and contribute to publications while navigating global regulatory expectations and development timelines.

Qualifications

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

Responsibilities

• Serves as statistical lead in project teams.
• Lead, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Late Development Statistics.
• Lead the interaction with Clinical, Regulatory, Statistical Programming, Data Management, and other company labs in designing and analyzing clinical trials.
• Interacts with Academic Research Organization, Contract Research Organization and external statistical consultants.
• Lead a team of statistical and/or programming staff on development projects as needed.
• Lead biostatistics in early or late clinical development planning to align with program objectives and regulatory needs.
• Independently identifies and anticipates problems in design, conduct, and analysis and proposes solutions.
• Develops protocols and data analysis plans and determines appropriate statistical methodology.
• May lead a team to ensure programs meet analysis requirements and regulatory standards.
• Evaluates software for planned analyses and needs for potential new methods.
• Analyzes data and interprets results to meet study objectives and communicates results to stakeholders.
• Represent biostatistics in regulatory interactions and advisory committee meetings.

Skills

Biostatistics

Clinical Development

Data Management

Data Processing

Data Science

New Program Development

Project Management

Regulatory Requirements

Statistical Analysis

Statistical Methods

Statistical Programming

Strategic Thinking

Study Design

Teamwork

Written Communication

Education

PhD or equivalent

Master's degree

Tools

SAS

R

Job description

Merck & Co. in Rahway, NJ, seeks a senior biostatistician to serve as statistical lead on drug/vaccine development programs. You will design analyses, lead cross-functional teams, and interact with Clinical, Regulatory, and external partners to ensure robust study outcomes.

You will mentor statisticians, drive methodological advances, and contribute to publications while navigating global regulatory expectations and development timelines.