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Cypress, CA
Job Type
Direct Hire
Nov 05, 2018
Job ID
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Biostatician - Cypress, CA or Stillwater, MN

Responsible for establishing statistical methodology on product development, clinical studies, analytical studies, validations, and process improvements. Responsible for supporting the organization with statistical methodology and analysis.
Responsible for ensuring the statistical applicability and validity of work performed for regulatory submissions, publications, and product/process improvements. Supports all applicable regulations and standards, including but not limited to domestic, international, and ISO requirements.

• Develops statistical rationale for the sample size justifications, analyses, and acceptance criteria of product development and process improvement protocols.
• Collaborate with company personnel to identify, isolate, and correct technical challenges for improving product and process reproducibility.
• Serves as statistical methodology expert for the organization and improves the organizations understanding and utilization of statistical methods.
• Understands and interprets validation documents with regards to regulatory requirements (e.g. CLSI, FDA/CDRH guidance, etc.) and participates in regulatory authority communications on statistical issues, as needed.
• Responsible for the creation of experimental study design plans, associated statistical analyses, summary tables, graphs, and reports.
• Compiles statistical methods for studies including but not limited to development, validation, clinical study, analytical study, process improvement, and marketing activity.
• Perform data analysis for research, product development, and manufacturing processes to determine the applicable statistical methodology.
• Communicates statistical concerns and solutions with pre-clinical, pre-analytical, clinical, and analytical development teams.
• Responsible for the review of data to confirm suitability for intended purpose or analysis.
• Provide oversight for clinical data management processes, including, but not limited to data consolidation, acceptability, formatting, storage, accuracy, and analysis.
• Monitor new methodologies and statistical techniques for the statistical analysis of clinical data.
• Develop training materials and present training on statistics and/or related topics.
• Assists with the evaluation, purchase, and implementation of statistical and Process Control System software and related tools.
• Responsible for performing assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies. Violations of EHS regulations or policies will be handled in accordance with the established Company disciplinary process.
• Perform other duties as assigned.

• Must have a Bachelor’s degree in Statistics, Biostatistics, Mathematics or Computer Science is required.
• Must have at least 5 years of experience in IVD, medical, pharmaceutical, or other related industry.
• Must have a proven ability to plan and implement statistical analyses independently and to use knowledge of clinical development and regulatory processes to advance projects.
• Must have a thorough understanding of statistical quality control and sampling strategies; applied multivariate analysis; regression, ANOVA and mixed models; Design of Experiments (DOE); nonlinear or logistic regression; reliability analysis; categorical data analysis; data mining techniques; and Six Sigma (optional) and their application as a problem identification and resolution tools.

Highly desirable to have working knowledge of biological science, clinical science, chemistry, FDA, and international regulations for design, conduct, and analysis of clinical trials (all phases).
Computational programming and simulation skills.
Proficient in SAS programming for statistical analyses and data manipulations.

Gateway Recruiting, INC – – 830.237.4443 –