Remote Biostatistics Senior Manager, Biosimilars

BioSpace; Washington (District of Columbia); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, and vision coverage

Life and disability insurance

Flexible spending accounts

Stock-based incentives

Time-off programs

Flexible work models

Job summary

Amgen is seeking a Biostatistics Senior Manager, Biosimilars US- Remote. You will lead statistical components across large product studies, influence development strategy, and defend statistical approaches both internally and externally.

The role requires advanced qualifications in biostatistics, solid experience with regulatory submissions, and collaboration with CRO partners to ensure high-quality statistical outputs.

Qualifications

• Doctorate degree and 2 years of Biostatistics experience OR
• Masters degree and 6 years of Biostatistics experience OR
• Bachelors degree and 8 years of Biostatistics experience

Responsibilities

• Implements standards in strategy, study design and statistical analysis.
• Plans and executes statistical contributions to protocols and reports.
• Provides statistical inputs to publications and regulatory documents.
• Oversees statistical work performed by CROs.
• Performs statistical analyses across multiple studies and initiatives.

Skills

Biostatistics

Statistical analysis

Regulatory submissions

Clinical publications

Education

Doctorate degree in Biostatistics

Masters degree in Biostatistics

Bachelors degree in Biostatistics or related field

Job description

Amgen is seeking a Biostatistics Senior Manager, Biosimilars US- Remote. You will lead statistical components across large product studies, influence development strategy, and defend statistical approaches both internally and externally.

The role requires advanced qualifications in biostatistics, solid experience with regulatory submissions, and collaboration with CRO partners to ensure high-quality statistical outputs.