Biostatistician/Statistical Project Manager for Regulatory Submission Studies
Harvard University T.H. Chan School of Public Health
Location: USA - MA - Boston
Internal Number: 59918BR
The Center for Biostatistics in AIDS Research (CBAR), an organization within the Harvard T.H. Chan School of Public Health, is responsible for the design, monitoring and statistical analysis of clinical trials and observational studies for several major NIH-funded clinical research networks. CBAR employs over 80 statisticians and epidemiologists including Harvard faculty, research scientists and staff. CBAR researchers have provided statistical leadership and support for clinical research networks for more than twenty-five years. Currently this includes infectious disease networks such as: the Adult AIDS Clinical Trials Groups (ACTG), the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT), and the Pediatric HIV/AIDS Cohort Study (PHACS). Results from studies have helped to establish the paradigm for the treatment and prevention of HIV and other infectious diseases, and contributed to US and international treatment and prevention guidelines.
CBAR is looking to hire a Biostatistician III/Statistical Project Manager to act as a senior statistician, collaborating directly with medical researchers in the design, implementation, analysis, and publication of IMPAACT clinical trials and observational studies, and as statistical project manager for IMPAACT's clinical trials involving regulatory submissions.
Job-specific responsibilities include, but are not limited to, the following.
Up to fifty percent (50%) of this position is dedicated to statistical project management for regulatory submission studies for the IMPAACT Network. The project management aspects of the role include but are not limited to:
Working with project leadership on:
Assignment of scientific work for regulatory submission studies (protocols, ancillary studies, data and specimen requests, validation, etc.) to MS-level Biostatisticians and Statistical Programmers.
Ensuring reasonable timelines for completing work and equitable distribution of assignments.
Development of efficient and compliant processes and practices within the organization
Working with the regulatory submission study statisticians on:
Developing and assisting with development of project plans for regulatory submission studies
Review of planning documents (e.g., Statistical Analysis Plan and Analysis Implementation Plan) from a regulatory submission perspective
Providing guidance on regulatory submission activities, processes, and deliverables
Identifying areas for training and improving work efficiency.
Assisting project leadership with:
Preparation and review of project management reports on work progress and completion
Audit/inspection preparations, conduct, and responses
Supervisor of CBAR MS-level Biostatistician I and IIs, Statistical Analyst/Programmers, or Statistical Programmers who work on studies with major regulatory components, as needed.
Other duties as assigned
The remainder of this position's time will be spent acting as a senior biostatistician, collaborating directly with medical researchers in the design, implementation, analysis and publication of IMPAACT Phase I through Phase IV clinical trials and observational studies. This position will also serve on internal committees.
Senior biostatistician responsibilities include, but are not limited to the following:
Conduct ongoing, periodic and final analyses of data, using specialized statistical techniques and programming
Review proposed protocol and study methodology, to ensure conformance with accepted statistical principles
Write statistical considerations for protocol documents and study proposals, according to appropriate statistical methods
Oversee development of data collection and data management methods to meet study objectives and allow valid analyses
Develop randomization and stratification materials in compliance with protocol design
Ensure the integrity of data collection, review, compilation and analyses by monitoring protocols, databases, and procedures
Identify potential or actual administrative or scientific problems; suggest and implement corrective action
Collaborate with clinicians on manuscripts, abstracts and other publications documenting study findings
Maintain professional knowledge and expertise as well as an awareness of emerging scientific areas
Assist senior researchers with supervision and direction of less experienced master's or bachelor's level biostatisticians; serve as the primary supervisor as needed
Take leadership roles in activities within CBAR and in a Project/Network, such as heading a CBAR committee or providing technical support to a Network-level committee or working group
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!
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 120 day orientation and review period.
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. More information regarding the University's COVID vaccination requirement, exemptions, and verification of vaccination status may be found at the University's
About Harvard University T.H. Chan School of Public Health
Harvard University is devoted to excellence in teaching, learning, and research, and to developing leaders in many disciplines who make a difference globally. The University, which is based in Cambridge and Boston, Massachusetts, has an enrollment of over 20,000 degree candidates, including undergraduate, graduate, and professional students. Harvard has more than 360,000 alumni around the world. The University has twelve degree-granting Schools in addition to the Radcliffe Institute for Advanced Study, offering a truly global education. Established in 1636, Harvard is the oldest institution of higher education in the United States.