BIOSTATISTICIAN II

This Position is Grant Funded

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

The Duke Human Vaccine Institute (DHVI) has established a place of national and international leadership in the fight against the major infectious diseases. Our investigators understand the power and opportunity of the team approach and are poised to make major new contributions to both national and global health challenges. Programs led by the DHVI are described below.

The Collaboration for AIDS Vaccine Discovery (CAVD) by grants from the Bill and Melinda Gates Foundation.  The Virology Quality Assurance Program (VQA) is National Institute of Health (NIH), National   Institute of Allergy and Infectious Diseases (NIAID) - Division of AIDS (DAIDS) funded contract that is designed to provide quality assurance and proficiency testing for virologic-based assays for HIV, and other viral pathogens that are conducted in NIH-supported laboratories. The External Quality Assurance Program Oversight Laboratory (EQAPOL) is NIAID/NIH funded resource located at Duke Human Vaccine Institute’s (DHVI) Immunology and Virology Quality Assessment Center (IVQAC) to support the development, implementation and oversight of external quality assurance programs that monitor laboratories involved in HIV/AIDS research and vaccine trials around the world.

The Collaborative Influenza Vaccine Innovation Centers (CIVIC) is NIAID/NIH funded contract lead by the Duke CIVIC Vaccine Center (DCVC). CIVICs is a multi-disciplinary group of collaborators that will iteratively discover, formulate and test influenza vaccine candidates to produce vaccines that have broader and more durable coverage against influenza strains that threaten human health.  Additionally, the DHVI is one of seven academic centers funded by the Centers for Disease Control and Prevention to conduct research studies addressing vaccine safety as part of the Clinical Immunization Safety Assessment (CISA) Project and also serves as the Coordinating Center for the US Platform to Measure Effectiveness of Seasonal Influenza, COVID-19, and other Respiratory Virus Vaccines for the Prevention of Acute Illness in Ambulatory Settings.

The Biostatistician II will be a statistician for the Duke Vaccine and Trials Unit which serves as the clinical research arm of the Duke Human Vaccine Institute. This work will include, but not be limited to, managing data from multiple clinical sites, completing data checks, analyses, and report generation within the project deadlines while working independently. The Biostatistician II will perform intermediate and advanced statistical analyses in collaboration with the Biostatistics team and Principle Investigators.

Statistical Support for the Duke Vaccine and Trials Unit

• Conduct statistical analysis of data from various biologic assays such as Luminex antibody binding, ELISA, biolayer interferometry (BLI), hemagglutination inhibition (HAI), and neuraminidase inhibition (NAI) titers.
• Conducts analysis of solicited and unsolicited adverse event clinical trial data and analysis of immunologic assays from clinical trials
• Use statistical models (e.g., logistic regression, Cox proportional hazards) to calculate vaccine effectiveness.
• Independently design, document and prepare analysis data sets for the as well as prepare reports describing the statistical methodologies used along with the interpretation of the statistical analysis.
• Learn and apply new statistical methods to the as needed.
• Collaborate with project leaders and develop analysis plans for new research questions that arise.
• Perform data management and data review using SAS and/or R for querying.
• Write efficient and complex programs in SAS and/or R for the creation of analysis data sets as well as statistical analyses.
• Manage multiple projects and deadlines, as well as provide solid estimates of statistical effort required for a research project. Communicate potential project issues with the lead researcher or Biostatistics team.
• Work with lead researchers on study design and the preparation of sample size and power calculations. Provide the lead researcher with final data tables, figures, and listings and interpretation of the results.

Manuscript Writing and Support

• Develop and present research for meetings or conferences as well as write statistical method sections for manuscripts and grant applications.
• Perform data management, statistical tasks or other duties as assigned.

Data Management and Quality Assurance

• Work with the Duke Program Team to develop study specific databases in REDCap, which includes Case Report Form development and design.
• Work with the Duke Program Team to develop methods of quality data management and quality control through database queries and database testing.
• Develop and write Standard Operating Procedures (SOPs) related to data analysis and data management.

• Position requires a minimum of a Master’s degree in (bio) statistics or related field and no relevant experience (preferred) or a Bachelor's degree in (bio) statistics or related field and 2 years relevant experience.
• Experience: Contribution to analysis of clinical trials and/or clinical research projects,

and/or participation in preparation of academic manuscripts or other written summaries

of analysis results, thorough experience with SAS or R, and solid command of the English language is required. prior role as a contributing statistician on clinical trials and/or clinical research projects that have delivered the agreed-upon end products on time. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE.

• Experience with R and SAS programming.
• Experience with biological research, assay analysis, development and assessment.
• Good written and oral communication skills.

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.