The Senior Staff Biostatistician will be responsible for providing technical expertise in biostatistics and to lead statistical evaluations of analytical and clinical validation studies for new in vitro diagnostics devices developed by Siemens Healthineers Laboratory Diagnostics. The role will provide significant statistical consulting to product development projects, conduct training, and contribute to development of reports, technical documents and procedures pertaining to statistical methods.
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.
The position will report to the Senior Director of Statistical Affairs within LD QT MBDQ Pre-market Biostatistics.
- Provides functional excellence in the areas of statistics and data science for the department.
- development, verification, validation, and monitoring of diagnostic products.
- 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.
- 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.
- Coordinates and interacts with technical experts within the organization or external experts, as required.
- May direct or develop complex technical activities.
- 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. Exceptional candidates with backgrounds bridging biological science and biostatistics will be considered.
- At least 5 years of experience in an FDA regulated clinical trials environment is required.
- 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. Familiarity with diagnostic clinical trial statistics is required.
- 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).
- 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 required.
- Experience with analysis of complex data from multiple source. Knowledge and experience using CDISC data standard models (CDASH, STDM, and ADAM).
- 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 remote.
Preferred Knowledge/Skills, Education, and Experience
- Masters degree or Ph. D. in Statistics or Biostatistics
- At least 10 years experience supporting analytical and clinical verification and validation studies for immuno-assays in infectious disease, clinical chemistry, and/or oncology.
- At least 5 years experience in SAS Programming and with Clinical Data Management Systems.
- Demonstrated progressive responsibility and statistical expertise to support analytical and clinical verification studies from planning through regulatory submission.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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