Sr Biostatistician

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

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role

The individual collaborates with scientific SME within development teams along with QA to author statistical analysis plans, perform statistical analysis, make statistical inference, and prepare/present reports summarizing findings. Also consults on the determination of study design and contributes to protocol development. Manages statistical activities for Analytical and Bioassay development projects including assay validation test design, data analysis, and assay validation protocol/report generation.

Travel Requirements

• 0-20% travel required

Essential Job Functions

• 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.

Scope Of Responsibility

Impacts a range of important customer, operational, project or service activities within the Analytical and Bioassay team. The focus is both on new assay development as well as data analysis associated with established projects. Guides and influences peers and/or management regarding development and/or improvement projects. Contributes to the strategic direction and operational decision-making of the organization.

Who You Are

• 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

Preferred Qualifications

• Bioassays or assay validation
• Works with agility and willing to embrace and implement change on a global scale.
• Applies technology to drive digitalization, improve quality and increase customer value.
• Excellent communication and facilitation skills (ability to lead cross-functional meetings, demonstrated ability to bring consensus among diverse cross-functional teams).
• Proficient knowledge and skills in statistical data analysis including but not limited to statistical application and proficiency for bioassays
• 1-3 years Demonstrated proficiency with statistical methods and applications
• Proficient knowledge of assay design, development and validation
• Proficient knowledge in application of FDA and EU regulations (cGMP, GLP)
• Proficient knowledge and application of ICH Q2 regulatory guidance
• Advanced knowledge and application of statistical analysis tools including Minitab and JMP

Pay Range for this position: $119,300-$178,900

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.

Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!