Biostatistician

Mass General Brigham is an integrated academic health care system, comprised of 16 member institutions, including Harvard-affiliated Massachusetts General Hospital and Brigham and Women's Hospital. Mass General Brigham Artificial Intelligence (AI) is responsible for enabling AI and advanced data science techniques to conceive, develop, validate, and bring clinically meaningful products and evidence to market to improve patient care. Mass General Brigham AI is the bridge between academic research and clinically relevant AI product development that combines the world-class clinical expertise of Mass General Brigham's 7,500 physicians and 80,000 employees that treat 1.8 million patients each year, with leading data science researchers, cutting-edge compute infrastructure and access to clinical workflows.

Within Mass General Brigham AI, the Digital Clinical Research Organization (CRO) aims to translate healthcare AI/machine learning algorithms to clinically regulated AI-based Software as a Medical Device (SaMD) products to be commercialized and used at the clinical point of care.

Acting under the supervision of the Lead Biostatistician and following established policies and procedures under a Quality Management System (QMS), the Biostatistician supports the planning, conduct, and reporting of data and statistical analyses with proper documentation pertaining to AI-based SaMD products and regulatory submission filings. The work is focused on Mass General Brigham AI's portfolio with industry collaborators and follows highly rigorous regulated product requirements with an accelerated industry-level pace to provide services to for-profit clients.

Principal Duties and 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.

* 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.

* 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.

Skills and Competencies:

* Expertise in statistical programming and database analysis software tools. R and REDCap are among the preferred tools.

* Familiarity with database programming languages such as SQL in addition to Python or similar language for data manipulation. Knowledge of SnowFlake is a plus.

* 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.

* Uphold the Mass General Brigham values to govern decisions, actions and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration.

Mass General Brigham is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.