Senior Biostatistician - Bioassay & Analysis Lead

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

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Job summary

MilliporeSigma in Rockville, MD seeks a Biostatistics expert to lead statistical analysis and study design for analytical and bioassay projects. You will collaborate with scientific SMEs and QA to craft analysis plans, validate assays and prepare comprehensive reports, ensuring regulatory-ready deliverables.

The role requires Ph.D./MA/BA in a relevant field with several years of experience in biostatistics, regulatory knowledge (FDA/ICH), and proficiency in Minitab/JMP.

Qualifications

• Ph.D. in biostatistics, statistics, or scientific discipline with minimum of 2 years’ relevant experience.
• MA/MS in biostatistics, statistics, or scientific discipline with minimum of 4 years’ relevant experience
• BA/BS in biostatistics, statistics, or scientific discipline with minimum of 8 years’ relevant experience

Responsibilities

• Provides sound strategic, scientific and statistical input to support client's assay development projects.
• Performs analysis and interpretation of assay validation data and generates reports
• Leads the project team's development of study analysis plans and statistical programs to perform analyses and display study data.
• Keeps abreast with current statistical and medical literature to ensure that sound methodologies are adopted.
• Fosters innovation in Biostatistics that will continuously enhance current statistical knowledge and practices.
• Ensures the scientific integrity of the research project and accuracy of the reported results.
• Performs sample size calculation and provides leadership in the statistical design of research projects.
• Reviews protocols and case report forms to ensure that protocol objectives are met, and standards are maintained.
• Provide support for client regulatory submissions, client audits, supplier audits, and internal audits.
• Reviews and approves assay validation and assay transfer protocols and reports in accordance with SOPs and regulatory expectations (e.g., GMP, ICH).
• Provide guidance and/or training for organization on assay validation concepts and requirements.
• Provide support for regulatory inspections.

Skills

Biostatistics

Statistical analysis

Study design

Regulatory knowledge

Minitab

JMP

GMP/GLP knowledge

FDA regulations

ICH Q2

Communication skills

Cross-functional leadership

Education

Ph.D. in biostatistics or related field

MA/MS in biostatistics or related

BA/BS in biostatistics or related

Tools

Minitab

JMP

Job description

MilliporeSigma in Rockville, MD seeks a Biostatistics expert to lead statistical analysis and study design for analytical and bioassay projects. You will collaborate with scientific SMEs and QA to craft analysis plans, validate assays and prepare comprehensive reports, ensuring regulatory-ready deliverables.

The role requires Ph.D./MA/BA in a relevant field with several years of experience in biostatistics, regulatory knowledge (FDA/ICH), and proficiency in Minitab/JMP.