Job Posting 1: Data Analyst 3
Location: Tarrytown, New York, 10591 (Remote)
Shift: 8 AM to 5 PM
Contract: 12 months
Description:
The Senior Biostatistician will be responsible for providing technical expertise in biostatistics and to lead statistical evaluations of development and clinical validation studies for new in vitro diagnostics devices developed by Siemens Healthineers Laboratory Diagnostics.
The role will interact cross-functionally with members of Clinical Affairs, Data Management, Medical Affairs, Regulatory Affairs and Global Assay Development to ensure high quality of data and analysis results used in regulatory submissions.
The role will leverage knowledge and experience in the areas of statistical techniques and programming to support product development goals within the Laboratory Diagnostics Division. This is an ideal role for candidates who are highly motivated, detail-oriented, have strong problem solving and scientific thinking skills, a collaborative mindset, and enthusiasm for topics related to biostatistics, data analysis, programming, presentation of data, and biological 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 Senior Director of Pre-Market Biostatistics.
Responsibilities
• Responsible for consulting on the design of clinical trials and statistical analysis methodology for studies directed towards the development, verification, validation, and monitoring of in vitro diagnostics devices developed by Siemens Healthineers Laboratory Diagnostics.
• Recommends appropriate statistical methodology for the evaluation of analytical and clinical study data.
• 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 sample size and statistical methods are specified to support study endpoints.
• Authors statistical sections 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
• Leads discussions and interacts with members of the Data Management and Clinical Affairs teams to align statistical endpoints of the clinical study to data collection, monitoring, and analysis activities.
• Authors 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.
Required Knowledge/Skills, Education, and Experience
• Minimum educational background of MS in statistics/biostatistics or other quantitative field. Exceptional candidates with backgrounds bridging biological science and biostatistics will be considered.
• At least 6 years of experience in biostatistics supporting development of medical diagnostics/devices. Candidate needs to demonstrate progressive experience in consulting and serving as lead consulting biostatistician on product development projects.
*Assay Migration Experience strongly desired.
• 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). Experience with Open Clinica preferred.
• Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, survival analysis, and associated sample size calculations.
• Knowledge of diagnostic clinical trial statistics is required.
• Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solution to novel problems.
• Familiar with FDA guidelines and CLSI guidelines applicable to medical diagnostics is a plus.
• Experience with analysis of complex data from multiple source.
• Ability to work independently and in project teams. Highly motivated and driven to exceed expectations.
• Strong communication skills in English, written and spoken. Strong ability for public speaking in audiences with mixed backgrounds. Able to distill complex statistical concepts in simpler terms to generalized audiences
• This position will be remotely based.
Benefits
• Potential for this assignment to be extended
Job Posting 2: Data Analyst 3
Location: Tarrytown, New York, 10591 (Remote)
Shift: Full time
Contract: 12 months
Description:
• Researches, analyzes, consolidates and interprets data using statistical and data analytics methods to create information on business-relevant topics, e.g. market environment, operational process and equipment performance etc.
• Acquires data from primary or secondary data sources and maintain databases/data systems.* Operates and optimizes pre-defined tools, applications and data bases/data management systems.
• Creates reports and communicates results to various internal and/or external stakeholders (e.g. management, customers). "Transfers" Is expected to integrate processes and results from other workflows and disciplines to develop and accountably propose appropriate and effective solutions for significant parts of solutions. "Senior Professional" Positions which need senior professional expertise, with extensive functional, commercial and/or technical knowledge in an area of competence. They integrate analysis, development, testing and implementation. They interpret and functionally influence policy and guidelines in their area of business / technology, and develop processes and systems to deliver functional objectives.
• They typically plan own work according to targets agreed, within an quarterly up to an annual cycle, by integrating resources in a project driven environment. They provide functional advice and guidance to colleagues and customers. Solid professional judgment and problem solving competence. Improves existing processes and approaches. Masters domain. Transfers and applies know-how to / in various contexts.
Requirements:
• EDC experience
• Knowledge of the electronic database system Medrio, RAVE or OpenClinica.
• Experience in CDISC as well as R or Python.
• A chartered professional qualification or equivalent is typically associated with grades (though not necessary).
• 5-8 years Deep professional know-how and experience in one Sub Job Family.
Benefits
• Potential for this assignment to be extended