GENERAL SUMMARY/ OVERVIEW STATEMENT:The Center for Clinical Investigation (CCI) is designed to provide infrastructure support to the investigative community, leading to a more effective and robust clinical research enterprise at Brigham and Women’s Hospital.This position involves project management for the statistical analyses and programming of clinical trials from small investigator initiated studies to large scale international clinical trials. For the projects in which the successful candidate participates, the person will become an integral part of the research team from research development to protocol design to pre-designed statistical plan to analyses to manuscript preparation. Qualified candidates will have advanced formal training in statistics or biostatistics including design and analysis of observational and experimental studies, and strong statistical computing skills. The incumbent will work in collaboration with various clinical and research groups within Brigham and Women’s Hospital to develop statistical analyses for investigational protocols with a focus on genetic protocols. The highly-qualified Biostatistician will support clinical investigation with a focus on genetic studies, including design and analysis of clinical studies, estimate sample size and power, interpret results and write statistical sections of papers and grants collaboration with investigators affiliated with Harvard Medical School, grant and protocol development and review, and teaching and mentoring of junior investigators.PRINCIPAL DUTIES AND RESPONSIBILITIES:1. Work with investigators and other research personnel independently or with minimal supervision. Possess a solid understanding of the purpose, objectives and goals of each trial.2. Collaborate with investigators to develop and perform statistical analyses (including planning, programming, analysis, interpretation and writing of results) for investigational protocols, subgroup and post-hoc projects and registry databases ending with preparation of manuscripts, abstracts and presentations at scientific meetings.3. Informal teaching and clear communication with investigators regarding project statistics.4. Design studies, perform power analysis and sample size justification.5. Ability to independently derive clinical trial databases and perform validation analyses of ongoing clinical trials.6. Contribute statistical sections and statistical guidance for grants and protocols. Determine and/or verify correct statistical testing to be performed in each analysis request.7. Analyze data and write results. Rearranges data in a format that allows for accurate use as well as possible integration and pooling across trials.8. Write methods sections9. Meet deadlines.10. Assure the maintenance of an up-to-date electronic archive recording data requests, statistical analyses, results, and data transmissions performed.11. Administrative tasks such as tracking hours for projects.12. Participate and contribute at research meetings.13. Maintain department service standards as outlined in the BWH Code of Conduct14. Other duties as requested by Biostatistics Director. These may include web page development, utility programs, documentation, and/or teaching.WORKING CONDITIONS:Office setting. Occasionally flexible hours may be required to meet deadlines.HOSPITAL WIDE RESPONSIBILITIES:Works within legal, regulatory, accreditation and ethical practice standards relevant to the position and as established by BWH; follows safe practices required for the position; complies with appropriate BWH and Mass General Brigham policies and procedures; fulfills any training required by BWH and/or Mass General Brigham, as appropriate; brings potential matters of non-compliance to the attention of the supervisor or other appropriate hospital staff.QualificationsQUALIFICATIONS:
PhD prepared in bio-statistics or a related field.
Needs to meet the requirements for appointment as a faculty member at Harvard Medical school, if applicable.
High proficiency in statistical computing.
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
Required: Data analysis, study design, grant writing.
Proficiency in software development (SAS, R, Python, Matlab) and developing machine learning and predictive models.
Desired: Clinical trials, case-control and cohort studies, statistical genetics, protocol monitoring, hierarchical, longitudinal, survival, categorical, nonlinear, and epidemiology.
Experience with programming in SAS, R and other statistical software and working with various database structures are crucial components of this position.
Ability to work independently as well as part of a team
Possess strong analytical skills
Ability to prioritize assignments, multi-task, make decisions based upon sound principles, and independently problem solve.
Ability to draft plans to resolve inaccuracies or other problematic situations.
Excellent verbal and written communication skills
Detail and process oriented
Ability to manage multiple projects simultaneously, including both long-term and short-term projects
Ability to develop novel ways to coordinate, manage and report data if required by new trials.
Demonstrated sound independent judgment and competencies in clinical research.
A high level of patient and data confidentiality and security must be maintained.
NOTICE OF CONDITIONSAppointment and/or employment at a Mass General Brigham affiliate is contingent upon compliance with all requirements for employment at the Mass General Brigham s affiliate. These requirements include without limitation:
United States Citizenship and Immigration Services rules concerning identity and right to work in the United States
Multi-state criminal background checks
Review of the Medicare Sanctions and Exclusions List
Pre-employment health and drug screening and annual compliance with the Influenza Vaccination Policy
Any offer of employment is contingent upon satisfactory completion of the above requirements for employment, as well as satisfactory completion of the credentialing and medical staff appointment process at the Mass General Brigham affiliate(s) where applicant will provide clinical services.Reference information, including academic and/or employment records, final evaluations and recommendations for future employment will be required.
