Sr Biostatistician

The businesses of Merck KGaA, Darmstadt, Germany•Rockville, MD

3d•$119,300 - $178,900

About The Position

The Sr Biostatistician collaborates with scientific subject-matter experts and quality assurance partners to develop statistical analysis plans, conduct statistical analyses and inference, and prepare and present reports summarizing findings. The role also 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 preparation of assay validation protocols and reports. The position provides strategic, scientific, and statistical input for assay development projects and supports client regulatory submissions, audits, and regulatory inspections. It reviews and approves assay validation and transfer protocols and reports in accordance with standard operating procedures and regulatory expectations, including GMP and ICH. The role also provides guidance or training on assay validation concepts and requirements, and contributes to project and organizational decision-making.

Requirements

Ph.D. in biostatistics, statistics, or a scientific discipline with at least 2 years of relevant experience; or an MA/MS in one of these fields with at least 4 years of relevant experience; or a BA/BS in one of these fields with at least 8 years of relevant experience.
Proficient knowledge and skills in statistical data analysis, including statistical applications and bioassays.
Demonstrated proficiency with statistical methods and applications; 1–3 years is stated in the qualifications.
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.

Nice To Haves

Experience with bioassays or assay validation.

Responsibilities

Provide strategic, scientific, and statistical input to support 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.
Promote innovation in biostatistics and enhance statistical knowledge and practices.
Ensure the scientific integrity of research projects and the accuracy of reported results.
Perform sample-size calculations and provide leadership in statistical research design.
Review protocols and case report forms to ensure study objectives are met and standards are maintained.
Support client regulatory submissions, client audits, supplier audits, internal audits, and regulatory inspections.
Review and approve assay validation and assay transfer protocols and reports in accordance with SOPs and regulatory expectations, including GMP and ICH.
Provide guidance and/or training on assay validation concepts and requirements.
Influence peers and/or management on development and improvement projects and contribute to organizational strategic direction and operational decisions.