Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 229189
Primary Location: United States-New York-Tarrytown
Other Locations: United States-Delaware-Newark
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Master's Degree
Travel Required: 10%
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.
With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.
For more information, please visit: http://www.usa.siemens.com/healthineers
Siemens US Talent Acquisition
The Staff Biostatistician will be responsible for providing technical leadership within the Statistical Affairs department in conduct 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 expertise in 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, Statistical, and Scientific Affairs (MSSA).
Responsible for designing, planning, and executing statistical analyses of studies directed towards the development, verification, validation, and monitoring of products within Siemens Healthineers Laboratory Diagnostics.
Develops and uses statistical methodology to evaluate analytical and clinical study data.
Interprets and evaluates test data and results of very 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.
Provides complex specifications and directions to clinical data analysts for creation of ADS and/or TLFs.
Contributes to the development of processes, procedures, and standards associated with analysis of clinical studies, data management, and reporting for regulatory submissions.
Mentors statistical staff on statistical methodology and programming. Assists in departmental training of staff.
Keeps abreast of new developments in statistics, industry development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
Required Knowledge/Skills, Education, and Experience
Minimum educational background of MS in statistics/biostatistics or other quantitative field.
8-10 years of experience, preferably in medical diagnostics or pharmaceutical industries.
Proficiency in statistical programming (SAS, R) and query of relational database systems (SQL). Certifications in SAS programming a plus.
Experience with extraction of data and reporting within Clinical Data Management systems (e.g. Medidata RAVE, Medrio, Oracle Clinical).
Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, sample size calculations.
Familiarity with diagnostic clinical trial statistics is a plus.
Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solution to novel problems.
Familiar with FDA guidelines and other regulatory requirements is a plus.
Experience with analysis of complex data from multiple source.
Ability to work independently and in project teams.
Excellent communication skills (written and spoken). Strong ability to interact with others and to distill complex concepts in simpler terms to generalized audiences
This position is located in Tarrytown, NY. Candidates may be considered for location in Glasgow, DE.