Sr Biostatistician

Mass General Brigham - Boston, MA

Full-time - Mid Level

Boston, MA

10,001+ employees

Ambulatory Health Care Services

About the position

The Biostatistician III position at Mass General Brigham involves planning, conducting, and reporting clinical studies and statistical analyses related to AI-based products. This role is integral to the Digital Clinical Research Organization (CRO) within Mass General Brigham AI, focusing on translating healthcare AI/machine learning algorithms into clinically regulated software medical devices. The position requires collaboration with a team to prepare statistical analysis plans, manage data processes, and ensure compliance with regulatory requirements, all while working in a remote office environment.

Responsibilities

• Demonstrate a solid understanding of the purpose, objectives, and goals of each assigned project within the Digital CRO and Mass General Brigham AI's project portfolio.
• Collaborate with the team to prepare statistical analysis plans, contribute to study designs, and execute statistical analyses for clinical studies of AI-based products.
• Apply strong coding capabilities and lead data mining of institutional clinical data archives to identify and curate cohorts based on study protocol criteria.
• Manage automated and reproducible data wrangling and transformation processes and address gaps or inconsistencies from clinical data archives and AI product output.
• Prepare statistical and data analyses independently or with minimal support from Lead Biostatistician.
• Identify, analyze, and interpret trends or patterns in complex data sets.
• Leverage strong writing experience to prepare analyses and create summaries/reports presenting the outcomes of AI validation and deployment studies.
• Ensure statistical analyses are performed and documented in accordance with a QMS and relevant regulatory requirements.
• Maintain up-to-date electronic archive recording data requests, code, statistical testing, and data transmissions performed.
• Participate in developing new software functionality to support client requirements that may be unique to each project.

Requirements

• PhD in biostatistics or a related field and a minimum of 3 years of experience with data analysis and programming in a regulated clinical trial setting.
• Expertise in R is required for advanced statistical programming and data analysis, including data manipulation, visualization, and implementation of complex statistical models.
• Working knowledge of REDCap is essential for database curation, management, exportation, and ensuring data integrity across clinical and research projects.
• Proficiency with statistical methods related to assessment of healthcare AI-enabled software medical devices is strongly desired.
• Experience in healthcare, data science, AI-enabled software medical device, 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.

Nice-to-haves

• High level of proficiency with database programming languages in particular Python and other similar language for data manipulation. Knowledge of SnowFlake is a plus.
• Knowledge of healthcare data, and medical coding such as ICD-10, RadLex, SNOMED, and technologies utilized within radiology including software (RIS, PACS, image viewer and reporting software) and imaging standards (DICOM) is highly preferred.
• Strong oral and written communication.
• Demonstrated organizational skills, careful attention to detail, and ability to prioritize tasks.
• Strong ability and willingness to identify challenges and roadblocks and proactively propose solutions.
• Excellent interpersonal skills and ability to work seamlessly with a high performing cross functional team.

Benefits

• Remote work flexibility
• Opportunities for professional development
• Supportive work culture focused on personal growth