Lead Biostatistician - Late-Stage Clinical Trials

MSD Malaysia; Rahway (NJ); Hybrid; USD 191,000 - 300,000; Full time

Benefits offered by this job

Medical benefits

401(k) retirement plan

Paid holidays

Vacation

Sick days

Relocation assistance

Visa sponsorship

Hybrid work arrangement

Travel 10%

Job summary

MSD Malaysia’s BARDS division seeks a Principal Scientist in Biostatistics to lead statistical activities for drug projects, design analyses for Phase II/III trials, and coordinate with medical, data coordination, statistical programming, and regulatory staff. A Ph.D.

in Biostatistics or Statistics is preferred; MS with substantial experience is acceptable. The role emphasizes leading a team, ensuring regulatory compliance, contributing to publications, and communicating results to project teams

Qualifications

• Ph.D. preferred; MS accepted with substantial relevant experience.
• Extensive knowledge of regulatory requirements and clinical trial design.
• Proven ability to lead statistical teams and collaborate across functions.

Responsibilities

• Provide biostatistical support for drug projects under management.
• Lead a team of statisticians or programmers as needed.
• Design and analyze late-stage clinical trials to support regulatory submissions.
• Prepare reports communicating trial results to teams and regulators.
• Engage with regulatory staff and investigators on study design and interpretation.
• Publish research results and present at meetings and seminars.

Skills

Biostatistics

Clinical Trial Management

Clinical Trials

Clinical Trials Analysis

Computing Software

Data Management

Data Science

Numerical Analysis

Regulatory Compliance

Regulatory Requirements

Scientific Leadership

Scientific Modeling

SOP

Statistical Analysis

Education

Ph.D. in Biostatistics or Statistics

MS in Biostatistics or Statistics

Job description

MSD Malaysia’s BARDS division seeks a Principal Scientist in Biostatistics to lead statistical activities for drug projects, design analyses for Phase II/III trials, and coordinate with medical, data coordination, statistical programming, and regulatory staff. A Ph.D.

in Biostatistics or Statistics is preferred; MS with substantial experience is acceptable. The role emphasizes leading a team, ensuring regulatory compliance, contributing to publications, and communicating results to project teams