Senior Biostatistician – DiaSorin Molecular LLC

DiaSorin Molecular LLC
Job Location
11331 Valley View
Cypress, CA 90630


As per local and Company requirements for DiaSorin Molecular LLC.  DiaSorin Molecular LLC offers a competitive compensation package includes Medical, Dental, Employer Life insurance, STD and LTD insurance, 6% match of 401k plan or Roth 401k plan with vesting schedule.

Job Description


Responsible for establishing statistical methodology used in product/process development and revision, clinical studies, validations, health hazard analyses, and marketing support. Ensures the statistical validity of regulatory submissions and publications and compliance with all applicable domestic and international regulations and standards.


Serves as statistical methodology expert for the organization. Determines/verifies statistical methodologies used for data collection and analysis

Monitors for new methodologies and statistical techniques for validating product analytical and clinical performance characteristics

Develops and presents training materials on statistics and related topics to improve understanding and utilization of statistical tools and methods throughout the organization

Provides input as requested for new and revised procedures and processes. Performs sample size calculations and provides justification of sample sizes

Reviews study plans and writes statistical sections of protocols (development, validation, clinical studies)

Analyzes data for product and process development and revision

Reviews Marketing materials where statistical data analyses are presented

Interacts with regulatory authorities on statistical regulatory issues as required

Communicates statistical issues and solutions with pre-clinical and clinical development teams



Master's degree (or equivalent) in Statistics, Biostatistics or related field is required 

Must have at least 5 years of experience in IVD, medical, pharmaceutical, or other related industry

Proven ability to plan and implement statistical analyses independently and to use knowledge of clinical development and regulatory processes to advance projects. Project management and communication skills

Experience supervising the work of others or consulting; preparing/reviewing regulatory submissions and/or peer reviewed publications

Highly desirable to have working knowledge in biological and clinical sciences

Working knowledge of FDA, international regulations for design, conduct, and analysis of clinical studies

Computational programming/simulation skills

Must have a thorough understanding of statistical quality control: Statistical Process Control (SPC) and sampling strategies; Applied Multivariate Analysis; Control Theory; Time Series Analysis; Regression, ANOVA and Mixed Models; Design of Experiments (DOE); Nonlinear or Logistic Regression; Reliability Analysis; Categorical Data Analysis; Data Mining Techniques(preferred); and Six Sigma and their application as problem identification and resolution tools

How to Apply

DiaSorin US Job Recruitment Portal


DiaSorin is an EEO/AA employer.  EEO is the Law |  

About Our Organization

At DiaSorin Molecular, we maintain our industry reputation as a market leader committed to providing products that accommodate the laboratory’s needs through reliable products, quality manufacturing practices and flexible solutions.  Our product lines include the Simplexa™ molecular chemistries run on the Integrated Cycler. We strive to be the first company to provide diagnostic solutions for emerging infectious diseases, with past accomplishments including assays for West Nile Virus, SARS, and Influenza A H1N1 (2009).

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