Senior Biostatistician: Lead Bioassay Design & Analysis

Millipore Corporation; Rockville (MD); On-site; USD 119,000 - 179,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Other perquisites

Job summary

MilliporeSigma in the United States is seeking a Biostatistician to collaborate with scientific SMEs and QA to author statistical analysis plans, perform analyses, and present findings. Travel up to 20% may be required as part of project work.

The role involves leading study analysis plans for Analytical and Bioassay development projects, contributing to protocol design, and providing support for regulatory submissions and audits with a focus on GMP/ICH guidelines.

Qualifications

• Ph.D. in biostatistics, statistics, or related field with ≥2 years of relevant experience
• MA/MS in biostatistics, statistics, or related field with ≥4 years of relevant experience
• BA/BS in biostatistics, statistics, or related field with ≥8 years of relevant experience
• Preferred: bioassays or assay validation and regulatory awareness

Responsibilities

• Collaborate with scientific SMEs and QA to author SAPs and perform statistical analysis
• Lead study analysis plans and create statistical programs for analyses and reporting
• Support regulatory submissions, audits, and validation activities for analytical/bioassay projects

Skills

Biostatistics

Statistical analysis

Study design

Regulatory knowledge

Data analysis

Education

Ph.D. in Biostatistics

MA/MS in Biostatistics

BA/BS in Biostatistics

Tools

Minitab

JMP

Job description

MilliporeSigma in the United States is seeking a Biostatistician to collaborate with scientific SMEs and QA to author statistical analysis plans, perform analyses, and present findings. Travel up to 20% may be required as part of project work.

The role involves leading study analysis plans for Analytical and Bioassay development projects, contributing to protocol design, and providing support for regulatory submissions and audits with a focus on GMP/ICH guidelines.