Senior Principal Biostatistics Lead - Clinical Trials

Merck; New Jersey; Vor Ort; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

Merck in New Jersey is seeking an experienced senior biostatistician to act as statistical lead on late-stage drug/vaccine projects. You will design and analyze clinical trials, coordinate statistical activities across Clinical, Regulatory, and Data Management teams, and interact with external CROs and consultants.

The role requires PhD or equivalent with extensive experience, or a Master’s with substantial experience, and strong leadership, communication, and programming skills (SAS, R) to

Qualifikationen

• PhD or equivalent with 9+ years relevant work experience, or Master’s with 12+ years.
• 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 leadership in a team environment.
• Publications in peer reviewed statistical/medical journals.

Aufgaben

• Serve as statistical lead in cross-functional teams for product development planning and execution.
• Lead a team of statisticians and/or programming staff on development projects as needed.
• Guide biostatistics in early to late clinical development to align with program objectives and regulatory needs.
• Identify and propose solutions to design/conduct/analysis problems in trials.
• Develop protocols and data analysis plans, choosing appropriate statistical methods.
• Evaluate software adequacy and potential need for novel methods.
• Analyze trial data and interpret results to meet study objectives.
• Prepare oral and written reports for project teams, management, regulators and investigators.

Kenntnisse

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

Ausbildung

PhD in statistics/biostatistics or related

Master's degree in statistics/biostatistics or related

Tools

SAS

R

Jobbeschreibung

Merck in New Jersey is seeking an experienced senior biostatistician to act as statistical lead on late-stage drug/vaccine projects. You will design and analyze clinical trials, coordinate statistical activities across Clinical, Regulatory, and Data Management teams, and interact with external CROs and consultants.

The role requires PhD or equivalent with extensive experience, or a Master’s with substantial experience, and strong leadership, communication, and programming skills (SAS, R) to