Sr Biostatistician

Merck•Rockville, MD

2d•$119,300 - $178,900

About The Position

The Sr Biostatistician collaborates with scientific subject matter experts in development teams and with Quality Assurance to author statistical analysis plans, perform statistical analyses and make statistical inferences, and prepare and present reports summarizing findings. The role consults on study design and contributes to protocol development. It manages statistical activities for Analytical and Bioassay development projects, including assay-validation test design, data analysis, and generation of assay-validation protocols and reports. The position supports assay development and established projects, contributes to project and organizational decisions, and guides peers or management on development and improvement projects. It also supports client regulatory submissions, audits, and regulatory inspections. Travel of 0–20% is required. The position does not offer work-authorization sponsorship; external applicants must be eligible to work in the United States.

Requirements

Ph.D. in biostatistics, statistics, or a scientific discipline and at least 2 years of relevant experience; or a master's degree in one of these fields and at least 4 years of relevant experience; or a bachelor's degree in one of these fields and at least 8 years of relevant experience.
Demonstrated proficiency with statistical methods and applications.
Proficient knowledge of assay design, development, and validation.
Proficient knowledge of FDA and EU regulations, including cGMP and GLP.
Proficient knowledge and application of ICH Q2 regulatory guidance.
Advanced knowledge and application of statistical analysis tools, including Minitab and JMP.
Excellent communication and facilitation skills, including the ability to lead cross-functional meetings and build consensus among diverse teams.
Ability to work with agility and embrace and implement change on a global scale.
Ability to apply technology to drive digitalization, improve quality, and increase customer value.
Eligible to work in the United States; work-authorization sponsorship is not offered.

Nice To Haves

Experience with bioassays or assay validation.
One to three years of proficiency in statistical data analysis, including statistical applications and bioassays.

Responsibilities

Provide strategic, scientific, and statistical input for client assay-development projects.
Analyze and interpret assay-validation data and generate reports.
Lead development of study analysis plans and statistical programs to analyze and display study data.
Keep current with statistical and medical literature and adopt sound methodologies.
Foster innovation in biostatistics to improve statistical knowledge and practices.
Ensure scientific integrity of research projects and accuracy of reported results.
Perform sample-size calculations and provide leadership in statistical design of research projects.
Review protocols and case report forms to ensure study objectives are met and standards are maintained.
Support client regulatory submissions, client and supplier audits, and internal audits.
Review and approve assay-validation and assay-transfer protocols and reports in accordance with SOPs and regulatory expectations, including GMP and ICH.
Provide organizational guidance or training on assay-validation concepts and requirements.
Support regulatory inspections.
Consult on study design and contribute to protocol development.
Manage statistical activities for Analytical and Bioassay development projects, including assay-validation test design, data analysis, and protocol and report generation.