39 applicants
Mass General Brigham · 5 days ago
Biostatistician
Boston, MA
Full-time
Onsite
Mid Level
3+ years exp
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Responsibilities
Demonstrate a solid understanding of the purpose, objectives, and goals of each assigned validation and clinical deployment project within the Digital CRO’s project portfolio.
Work closely with the Lead Biostatistician and independently to assist with preparing statistical analysis plans and contribute to the design of study protocols.
Execute statistical analyses for regulatory filings and clinical deployment studies of AI-based SaMD products.
Enable data mining of institutional data sources (with emphasis on radiology imaging archive) to identify and curate appropriate records based on study protocol criteria to generate study cohorts.
Apply strong computational skills to perform and create automated data wrangling and transformation processes and address gaps or inconsistencies from clinical data archives and AI output.
Identify, analyze, and interpret trends or patterns in complex data sets.
Document analyses and create summaries/reports presenting the outcomes of AI validations and deployments.
Ensure statistical analyses are performed and documented in accordance with a quality management system and relevant regulatory requirements.
Contribute to the documentation of statistical analyses including for clinical study reports and scientific manuscripts.
Support maintenance of an up-to-date electronic archive recording data requests, statistical testing, and data transmissions performed.
Participate in developing new software functionality to support client requirements that may be unique to each project.
Qualification
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Required
MS/MPH in biostatistics or a related field with a minimum of 3 years of experience or PhD in biostatistics or related field with a minimum of 1 year of experience with data analysis and programming in regulated clinical trial setting.
Proficiency with statistical methods related to assessment of healthcare AI-based SaMD is strongly desired.
Preferred
Experience in healthcare, data science, AI-based SaMD, and regulated product interactions with the FDA is preferred.
Familiarity with machine learning and deep learning models concepts, including containerization software such as Docker, and packages such as PyTorch and TensorFlow.
Prior experience as a team member and collaborator in a CRO environment working closely with PIs and industry sponsors.
Knowledge of SnowFlake is a plus.
Company
Mass General Brigham
Mass General Brigham specializes in providing medical treatments and health diagnostics services.
10,001+ employees
H1B Sponsorship
Mass General Brigham has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (87)
2022 (83)
2021 (71)
2020 (49)
Funding
Current Stage
Late StageLeadership Team
A
Anne Klibanski
President and Chief Executive Officer
Steve Flammini
Chief Technology Officer
Recent News
2024-04-24
2024-04-24
Company data provided by crunchbase
