Sr Biostatistician

About Us:

As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system. Founded by Brigham and Women's Hospital and Massachusetts General Hospital, Mass General Brigham supports a complete continuum of care including community and specialty hospitals, a managed care organization, a physician network, community health centers, home care and other health-related entities. Several of our hospitals are teaching affiliates of Harvard Medical School, and our system is a national leader in biomedical research.

We're focused on a people-first culture for our system's patients and our professional family. That's why we provide our employees with more ways to achieve their potential. Mass General Brigham is committed to aligning our employees' personal aspirations with projects that match their capabilities and creating a culture that empowers our managers to become trusted mentors. We support each member of our team to own their personal development-and we recognize success at every step.

Our employees use 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.

The Opportunity:

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-enabled software medical device products to be commercialized and demonstrate their impact 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 III combines experience in planning, conducting, and reporting clinical studies as well as statistical analyses with software proficiency to prepare required deliverables pertaining to AI-based products validation, regulatory submission filings and clinical impact assessment studies. 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 expert services to for-profit clients.

PRINCIPAL DUTIES AND 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.

WORKING CONDITIONS

* Remote office environment. Occasional travel to MGB headquarters in Assembly Row

<2 weeks/year) may be required.

* 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.

Skills and Competencies:

* 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.

* 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.