Biostatistician/Statistical Project Manager for Regulatory Submission at Harvard University in Boston, Massachusetts

Job Description:

Harvard University


Position Title: Biostatistician/Statistical Project Manager for Regulatory Submission

Req ID: 67108BR

School or Unit: Harvard T.H. Chan School of Public Health

Description: Job Summary

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 national and international NIH-funded clinical research networks. CBAR employs over 100 statisticians and epidemiologists including Harvard faculty, research scientists, and staff. Investigators within CBAR have provided statistical leadership and support for clinical research networks for thirty-five years. Currently, this includes infectious disease networks such as: the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (formerly known as AIDS Clinical Trials Network (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 international treatment and prevention guidelines.

CBAR has a hybrid work environment which includes a combination of on-campus/in-person work and remote work.

The position is located in the Center for Biostatistics in AIDS Research (CBAR) within the Harvard T. H. Chan School of Public Health. Since 1989, CBAR and the Harvard T.H. Chan School of Public Health have provided a strong program for growth and development for Master's-level Biostatisticians - including a defined career path and opportunities for continuing education and attendance at professional meetings.

CBAR is looking to hire a Biostatistician/Statistical Project Manager for Regulatory Submission Studies 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.

Position Description

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 work (protocols, ancillary studies, data and specimen requests, validation, etc.) to MS-level Biostatisticians and Statistical Programmers.
• Ensuring reasonable timelines and prioritization for completing work and equitable distribution of assignments.
• Identifying areas for training and improving work efficiency.

Working with the regulatory submission study statisticians and programmers on:

• Developing project plans for regulatory submission studies
• Reviewing drafts of planning documents (e.g., Statistical Analysis Plan and Analysis Implementation Plan) from a regulatory submission perspective
• Providing guidance and training on regulatory submission activities, processes, and deliverable
• Audit/inspection readiness

Assisting project leadership with:

• Development of efficient and compliant processes, practices, standards, documents, templates, guidance, and training for regulatory submission studies within the organization
• Preparation and review of project management reports on work progress and completion
• Leading and preparing agendas for submission study statistician/programmer meetings and regulatory working group meetings
• Communications with pharmaceutical company partners, including tracking requests and decisions
• Audit/inspection preparations, conduct, and responses
• Supervise CBAR MS-level Biostatistician IIs 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 principle
• 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

PLEASE NOTE: This position has a term end date of November 30, 2027, with strong likelihood of extension.

Please attach the following when applying: 1) Resume, 2) Cover letter, 3) Transcript (official or unofficial) from MA/MS program and 4) Names and email addresses for three (3) professional references.

Basic Qualifications

• Master's Degree in Biostatistics, Statistics, Epidemiology, or a closely related field required
• 5+ years of related statistical experience, including with multi-center clinical trials involving regulatory submissions required; a combination of experience and education may be considered
• Experience with statistical software (such as SAS, Stata, etc.) required

Please attach the following when applying: 1) Resume, 2) Cover letter, 3) Transcript (official or unofficial) from MA/MS program and 4) Names and email addresses for three (3) professional references.

Additional Qualifications and Skills

The following job-specific skills and competencies are preferred:

• Two-year MA/MS program
• Prior supervisory experience
• Statistical experience with multi-center clinical trials, including Phase I or Phase I/II trials, or equivalent collaborative statistical experience
• Statistical experience with clinical trials supporting regulatory approval (e.g., FDA or EMA)
• Highly specialized and technical knowledge of statistical analysis techniques and principles including categorical data and censored failure time data analysis
• Advanced computer skills and experience with major statistical computing packages
• Experience in effectively collaborating with study chairs, medical officers, protocol specialists and database managers
• Experience with independently analyzing data from clinical trials using standard statistical techniques
• Experience contributing to the writing of manuscripts, abstracts, and other publications documenting study findings
• Experience with SAS, or strong background in other relevant packages (e.g., STATA, S-PLUS or R)
• Experience with MS Office (Word, Excel, PowerPoint)
• Familiarity with medical terminology
• Strong written and verbal communication skill

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

Additional Information

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 120 day orientation and review period.

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The health of our workforce is a priority for Harvard University. With that in mind, we strongly encourage all employees to be up to date on CDC-recommended vaccines.

Benefits

We invite you to visit Harvard's Total Rewards website (https://hr.harvard.edu/totalrewards) to learn more about our outstanding benefits package, which may include:

• Paid Time Off: 3-4 weeks of accrued vacation time per year (3 weeks for support staff and 4 weeks for administrative/professional staff), 12 accrued sick days per year, 12.5 holidays plus a Winter Recess in December/January, 3 personal days per year (prorated based on date of hire), and up to 12 weeks of paid leave for new parents who are primary care givers.
• Health and Welfare: Comprehensive medical, dental, and vision benefits, disability and life insurance programs, along with voluntary benefits. Most coverage begins as of your start date.
• Work/Life and Wellness: Child and elder/adult care resources including on campus childcare centers, Employee Assistance Program, and wellness programs related to stress management, nutrition, meditation, and more.
• Retirement: University-funded retirement plan with contributions from 5% to 15% of eligible compensation, based on age and earnings with full vesting after 3 years of service.
• Tuition Assistance Program: Competitive program including $40 per class at the Harvard Extension School and reduced tuition through other participating Harvard graduate schools.
• Tuition Reimbursement: Program that provides 75% to 90% reimbursement up to $5,250 per calendar year for eligible courses taken at other accredited institutions.
• Professional Development: Programs and classes at little or no cost, including through the Harvard Center for Workplace Development and LinkedIn Learning.
• Commuting and Transportation: Various commuter options handled through the Parking Office, including discounted parking, half-priced public transportation passes and pre-tax transit passes, biking benefits, and more.
• Harvard Facilities Access, Discounts and Perks: Access to Harvard athletic and fitness facilities, libraries, campus events, credit union, and more, as well as discounts to various types of services (legal, financial, etc.) and cultural and leisure activities throughout metro-Boston.

Department Office Location: USA - MA - Boston

Job Code: RS0358 Statistician III

Job Function: Research

Work Format: Hybrid (partially on-site, partially remote)

Sub Unit: ------------

Salary Grade: 058

Department: Center for Biostatistics in AIDS Research


Union: 00 - Non Union, Exempt or Temporary

Time Status: Full-time

Pre-Employment Screening: Education, Identity


Commitment to Equity Diversity Inclusion and Belonging: At the Harvard T.H. Chan School of Public Health, we believe that diversity is integral to the Harvard experience and our mission of improving public health education, research and policy. Diversity of cultural backgrounds, identities, lived experiences, perspectives, and ways of understanding the world enriches our community and enables us to best meet the public health needs of the United States and the world. Ongoing learning and development related to diversity allows for both individual and institutional growth, and is necessary to foster and sustain a culture of inclusion. To achieve this, we are committed to ensuring equitable access to opportunities for learning, living, and working at the Harvard Chan School. We maintain an unwavering dedication to diversity, inclusion, and belonging as core to our institutional values and to actively counter, minimize, and address racism, sexism, xenophobia, homophobia, gender bias, and all forms of discrimination.

Learn more about the School's mission, objectives, and core values, our Principles of Citizenship, and our diversity, inclusion, and belonging initiatives.

EOE 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, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law.

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