Associate Director of Statistical Programming

Company: Harvard University
Location: Cambridge
Posted on: January 25, 2023

Job Description:

Associate Director of Statistical ProgrammingHarvard T.H. Chan School of Public Health61250BRJob 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 more than 30 years. Currently this includes infectious disease networks such as: the Adult AIDS Clinical Trials Groups (ACTG), the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (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.

Reporting directly to the Director of Biostatistics and Programming, the Associate Director for Programming is responsible for leading the statistical programming efforts for a busy research center. The individual will be responsible for collaborating with CBAR Leadership, project PIs, biostatisticians, and Core programmers as well as the CBAR Quality Management Team, IT professionals, Internal Resource Committees, external collaborators, and other colleagues in the creation, implementation, and maintenance of statistical programming infrastructure and deliverables for each project. The Associate Director will lead the effort to continuously improve programming processes to conform to evolving industry standards and participate in the ongoing review and development of quality systems and processes, including CDISC implementation and other internal/external initiatives.

The Associate Director will manage the priorities and expectations of the CBAR Programming Core comprised of approximately 10 programmers who design and implement expert modules and systems supporting protocol-specific statistical programming and project priorities for the AIDS Clinical Trials Group (ACTG) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT). This includes high-level programming projects, including SAS, BASH, and Python, and ad hoc protocol-specific programming requests. As the process owner for Core projects, the Associate Director is responsible for timely review and final approval of program specifications and requirements (including testing). Position Description The Associate Director will directly supervise three programming managers and other senior Core programming staff. Responsibilities also include personnel decision making at all levels of the Core, including hiring, promotion recommendations, and disciplinary actions.. This position mentors programming staff and coordinates with CBAR Training Committee with respect to the training needs of masters and doctoral-level statisticians and epidemiologists.

This individual must possess extensive experience and proven skills in the use of SAS within a Statistical Programming environment and complete knowledge and understanding of the statistical programming processes, procedures, and roles. This individual will use knowledge of CDISC SDTM and ADaM standards to support Biostatistics in statistical analysis. Additionally, the successful candidate will use their strong people management skills and supervisory skills to provide direct line management to the statistical programmers, identify training needs and opportunities for optimizing staff utilization and employing the most efficient practices. -

Duties and responsibilities include, but are not limited to, the following:

• Signatory for CBAR Programming SOPs with responsibility for document revisions, CAPA management, response to internal audit, statistical programming representative for external audits/inspection
• Lead the statistical programming activities, which include identifying Programming Core priorities and commitments, including assessment of programming needs and requirements, allocation of resources including for ad-hoc projects, review and final approval of program specifications and requirements
• Manage, cultivate, and establish requirements for a pipeline of statistical programming projects. Projects include macro development, script development, study-specific work, standardization efforts, ad-hoc projects, etc.
• Directly supervise the Manager of Programming Systems, the Manager of Programmer Development, and the Chief Data Administrator providing oversight for advanced application design and programming projects, Core programmer training, and clinical data standardization, respectively
• Collaborate with the CBAR IT team to ensure thorough and smooth testing associated with critical hardware and software updates
• Primary liaison with the ACTG/IMPAACT Data Management Center in Amherst, NY; responsible for maintaining a solid working relationship to ensure the harmonization of programming systems and deliverables between the two organizations
• Supporting statisticians and epidemiologists with external collaborators to ensure efficient and secure data transfer
• Coordinate with the CBAR Training Committee with respect to the training needs of master- and doctoral-level statisticians and epidemiologists PLEASE NOTE: This position has a term appointment of November 30, 2027 with the possibility for extension. It is also a hybrid position and will be based in Boston, MA. Additional detail pertaining to this position will be discussed during the interview process. All remote work must be performed in a state in which Harvard is registered to do business (Connecticut, Massachusetts, Maryland, Maine, New Hampshire, New York, Rhode Island, Vermont, California, Georgia, Illinois, New Jersey, Virginia, and Washington).
  - Basic Qualifications
  • Minimum of 7 years' post-secondary education or relevant work experience is required
  • Supervisory experience is required Additional Qualifications and Skills The following job-specific skills and competencies are preferred:
    • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
    • Proven leadership skills with prior management and extensive supervisory experience. Proven history of managing programming capability and projects in a research setting.
    • Experience with SAS, Bash, Linux, and Python are highly desirable.
    • Excellent knowledge of clinical trial research methodologies, CDISC, ICH, GCP, and 21 CFR Part 11 rules and regulations.
    • At least seven years of high-level statistical programming skills in a clinical data environment or research setting, preferably with clinical trial data.
    • Proven skills in the use of SAS and a scripting language within a Statistical Programming environment
    • preferably with clinical trial data.
    • Strong team player that has a customer service approach and is solution-oriented.
    • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
    • Strong written and verbal communication skills; technical writing experience is desirable. 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 180 day orientation and review period. - ----------
            
            Harvard University continues to place the highest priority on the health, safety and wellbeing of its faculty, staff, and students, as well as the wider community. Please note that all new employees will be required to provide confirmation of primary series COVID-19 vaccination upon hire, as detailed on our COVID-19 Vaccine Requirement Webpage . Harvard University Health Services employees and other health care individuals are also required to be up to date on vaccination as described by the CDC. Individuals may claim exemption from the vaccine requirement for medical or religious reasons. Additional information regarding this requirement, exemptions, verification of vaccination status, and other related policies and resources may be found on the University's COVID-19 Information Website . Job FunctionInformation Technology, Research, TechnicalLocationJob Code384359 Sys Prog/Analysis/Admin SrSub-Unit------------DepartmentCenter for Biostatistics in AIDS ResearchCommitment 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 and our diversity, inclusion, and belonging initiatives. 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.

Keywords: Harvard University, Cambridge , Associate Director of Statistical Programming, Executive , Cambridge, Massachusetts