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The Department of Biostatistics is a very busy and diverse department focused on research and teaching. Our 70+ faculty are leaders in the development of statistical methods for clinical trials and observational studies, studies on the environment, computational biology, and genomics/genetics. We offer degree programs in biostatistics, computational biology and data science; currently, more than 200 students are enrolled in these programs.

Our team invites applications for a Regulatory and Compliance Manager position in the National Studies on Air Pollution and Health group (https://www.hsph.harvard.edu/nsaph/). The work will involve close collaboration with Dr. Dominici, co-Director of the Harvard Data Science Initiative and Clarence James Gamble Professor of Biostatistics, Population and Data Science (https://www.hsph.harvard.edu/francesca-dominici/), and her team of PhD students, postdoctoral fellows and data scientists. The position will be supervised by Senior Research Scientist, Dr. Danielle Braun, who is a senior member of the Dominici Lab. The team's current research focus is on the development and implementation of statistical and machine learning methods to estimate causal effects of environmental exposures on health in the presence of high dimensional data, multiple exposures, strong confounding, and complex, non-linear relationships. The team has access to many rich datasets in these areas, including high resolution air pollution data and health data from Medicare, Medicaid, and private insurance companies, to which these methods will be applied in order to answer high impact scientific questions. The Regulatory and Compliance Manager will manage the complex communications, coordination and documentation associated with the use of regulated data and IRB compliance across multiple institutions and will serve as the primary point of contact between the Harvard Longwood Campus (HLC) research team, IRB office, and NSAPH collaborators. Additionally, this person will manage the Data Use Agreements (DUA) with the Centers for Medicare and Medicaid Services (CMS), and any other DUAs as applies, and communications with CMS as needed. This person will work to ensure that all compliance concerns affecting NSAPH are monitored and responded to as needed.

Additional Qualifications and Skills

The following job-specific skills and competencies are preferred:

• Previous experience working with CMS data, CMS DUA, and IRB review process
• Solid working knowledge of federal and state regulations governing human subjects research
• Excellent organizational skills and attention to detail
• Strong writing, editing and verbal and written communication skills
• Communicates quickly and effectively with a wide range of stakeholders
• Project management skills
• Strong analytical skills and problem solving skills
• Works well independently and with all levels of staff, faculty, and external contacts
• Experience prioritizing and multi-tasking in a busy environment while maintaining superior customer service
• Uses discretion with sensitive and confidential information
  

The following cultural competencies are also preferred:

• Awareness of and aptitude to appropriately and effectively understand, respect, and adapt to cultural and identity-based difference within group environments
• Knowledge of and commitment to concepts and issues tied to social justice, diversity, equity, and inclusion
• Skills related to creating and supporting an environment that allows for inclusion, effective intercultural engagement, and personal humility and authenticity
• Experience fostering and reinforcing an environment that values unique experiences, cultures, backgrounds, and goals

Additional Information

Harvard University offers an outstanding benefits package including:

• Time Off: 3-4 weeks paid vacation, paid holiday break, 12 paid sick days, 12+ paid holidays, and 3 paid personal days per year.
• Medical/Dental/Vision: Excellent and affordable medical, dental & vision plans, with coverage beginning as of an employee's start date.
• Retirement: University-funded retirement plan with full vesting after 3 years of service.
• Tuition Assistance & Reimbursement Programs: $40 per class at the Harvard Extension School, discounted options through participating Harvard graduate schools, and reimbursement options for accredited schools outside of Harvard.
• Transportation: 50% discount on MBTA passes, as well as additional options (rideshare, biking, etc.) to assist employees in their daily commute.
• Wellness & Professional Development: Programs and classes at little or no cost, including stress management, hard & soft skills development, career planning, massages, nutrition, meditation, and complimentary health services. Additionally, access to Harvard athletic facilities, libraries, campus events -- and many discounts for various cultural and leisure activities throughout metro Boston.

Join the Harvard T.H. Chan School of Public Health to support our mission of health research and education, and to be a part of the oldest institution of higher learning in the country!

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• The Harvard T.H. Chan School of Public Health does not provide visa sponsorship, now or in the future, for staff positions.
• Harvard University requires pre-employment reference checks and background screenings.
• This position has a 90 day orientation and review period. The O&R period will be waived for any internal Harvard employee transfers.

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The University requires all Harvard community members to be fully vaccinated against COVID-19 as detailed in Harvard's Vaccine Requirements. Individuals may claim exemption from the vaccine requirement for medical or religious reasons.

Salary Grade: 056

Union: 55 - Hvd Union Cler & Tech Workers

Commitment to Equity, Diversity, Inclusion, and Belonging
Harvard University views equity, diversity, inclusion, and belonging as the pathway to achieving inclusive excellence and fostering a campus culture where everyone can thrive. We strive to create a community that draws upon the widest possible pool of talent to unify excellence and diversity while fully embracing individuals from varied backgrounds, cultures, races, identities, life experiences, perspectives, beliefs, and values.

EEO Statement
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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