Design clinical validity, clinical utility, health economics, and clinical experience studies.
Evaluate evidentiary requirements.
Contribute to proposals, FDA pre-submissions, and study protocols (selecting endpoints, power and sample size calculations, and analysis plans).
Review case report forms and data transfer requirements.
Author statistical analysis plans.
Apply rigorous statistical methodology and programming to monitor clinical data quality.
Develop evidence for clinical predictive models in clinical studies and trials.
Conduct simulation studies.
Communicate statistical results in tables, figures, and listings; statistical analysis reports; clinical study reports; abstracts; manuscripts; regulatory submissions; presentations; and marketing collateral.
Evaluate investigator sponsored study designs and analysis plans, evidence developed for external molecular tests, and applicability of novel statistical techniques.
Requirements
Master’s degree in Biostatistics or field as outlined in the essential duties; or Bachelor's degree in Biostatistics or field as outlined in the essential duties, plus 2 years of experience in lieu of a Master’s degree
4+ years of relevant work experience, as outlined in the essential duties
Demonstrated statistical experience in molecular diagnostic, drug, or medical device development; epidemiology; public health; or healthcare
Professional working knowledge of theoretical and applied statistics
Strong statistical programming skills (SAS, R, or Python)
Strong verbal, written, and graphical communication/presentation skills
Proficiency with Microsoft Office programs, such as (Word, Excel, PowerPoint, Outlook, OneNote, etc.)
Ability to work independently, prioritizing and producing high quality results
Ability to collaborate effectively as part of a cross-functional team
Demonstrated ability to perform the essential duties of the position with or without accommodation
Authorization to work in the United States without sponsorship.
Tech Stack
Python
Benefits
paid time off (including days for vacation, holidays, volunteering, and personal time)
paid leave for parents and caregivers
retirement savings plan
wellness support
health benefits including medical, prescription drug, dental, and vision coverage