Senior Biostatistics Lead — Clinical Trials & Regulatory

Merck & Co.; Upper Gwynedd Township (Montgomery County); Hybrid; USD 210,000 - 331,000; Full time

Job summary

Merck & Co. in Rahway, NJ, seeks a senior Biostatistics lead within BARDS to guide late-stage development programs.

You will design trials, lead statistical analyses, and coordinate across Clinical, Regulatory, Data Management, and Statistical Programming teams to advance vaccines and drugs. You will mentor junior statisticians, develop protocols, and apply advanced methodologies to meet worldwide regulatory requirements, while communicating results to project teams and regulators, contributing

Qualifications

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience.
• Master's degree with a minimum of 12 years relevant work experience.

Responsibilities

• Serves as statistical lead in cross-functional project teams.
• Lead, develops, coordinates, and provides biostatistical support for drug/vaccine projects in Late Development Statistics.
• Lead interaction with Clinical, Regulatory, Statistical Programming, Data Management and other Merck Research Laboratories Scientists in designing and analyzing clinical trials and coordinating statistical activities.
• Interacts with Academic Research Organization, Contract Research Organization and external statistical consultants.
• Lead cross-functional teams for strategic planning and execution for product development.
• Lead a team of statistical and/or programming staff assigned to a development project as needed.
• Ensure study designs meet worldwide regulatory and marketing needs; anticipate problems and propose solutions.
• Develop protocols and data analysis plans and determine appropriate methodological approaches.

Skills

Statistical leadership

Clinical trial design

Project management

SAS

R

Regulatory knowledge

Communication skills

Biostatistics

Education

PhD or equivalent in statistics/biostatistics

Master's in statistics/biostatistics or related discipline

Tools

SAS

R

Job description

Merck & Co. in Rahway, NJ, seeks a senior Biostatistics lead within BARDS to guide late-stage development programs.

You will design trials, lead statistical analyses, and coordinate across Clinical, Regulatory, Data Management, and Statistical Programming teams to advance vaccines and drugs. You will mentor junior statisticians, develop protocols, and apply advanced methodologies to meet worldwide regulatory requirements, while communicating results to project teams and regulators, contributing