Job Title – Biostatistician 6
Job Location – Tarrytown NY
Length – Contract (12 Months+)
Description:
The Biostatistician will be responsible for supporting the statistical design and analysis of studies directed towards the development, verification, validation, and monitoring of products within Siemens Healthineers Laboratory Diagnostics. The role will interact cross-functionally with members of Clinical Affairs, Design Quality Engineering, Design Quality Systems, and Global Assay Development to ensure high quality of data and analysis results used in regulatory submissions.
The role will leverage knowledge of statistical methodology and data management practices to meet product development goals within the Laboratory Diagnostics Division.
This is an ideal role for candidates who are detail-oriented, have strong problem solving and scientific thinking skills, a collaborative mindset, and enthusiasm for topics related to data analysis, programming, presentation of data, and science. A willingness to share this enthusiasm with colleagues and to have fun is a must for our team.
The position will report to the Director of Statistical Affairs within Medical, Biostatistical, and Design Quality (MBDQ).
Responsibilities
• Responsible for contributing to the design and planning of internal and external evaluations of Siemens Products. The role will be expected to plan and execute statistical analyses of studies directed towards the development, verification, validation, and monitoring of products within Siemens Healthineers Laboratory Diagnostics.
• Interprets and evaluates test data and results of complex studies and develops appropriate recommendations.
• Perform detailed review of clinical study protocols and development plans to ensure that the appropriate data collection and statistical analysis requirements are specified to support study endpoints.
• Develops the statistical component of protocols for development-phase projects
• Ensure that clinical monitoring plans, data management plans, and statistical analysis plans are harmonized and ensure delivery of high quality data and analysis results for regulatory submissions
• Interact with members of the Data Management and Clinical Affairs teams to align scientific aspects of the clinical study to data collection, monitoring, and analysis activities.
• Develops Statistical Analysis Plans (SAP) for clinical studies, maintains plan through life cycle of study, and executes analyses per plan.
• Develops statistical analysis programs to merge complex data structures from multiple databases, create analysis data set (ADS) and generate tables, listings, and figures (TLF) for reports.
• Participate in development of database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations. Ensures data specifications align with statistical analysis requirements and goals.
Best,
Kushal Shah
APN Software Service INC
609-357-9180 (Direct)