- Manage, track, and analyze data sets related to the evaluation immune HIV-1 vaccines for human and preclinical studies. Independently generate descriptive and basic test statistics, analysis of basic data requests and learn new statistical methods as needed and applies new skills to future projects.
- Documents analyses, creates summaries and presents results in written and verbal form to requestors. Position requires the ability to work on any phase of a manuscript project, from initial meeting/discussion to final submission.
- Builds documentation and organizational skills to effectively return to a trial or manuscript project after long intervals.
- Contributes meaningfully to discussions of analyses and identifies next steps for analyses.
- Designs analysis data set specifications through writing own SAS and or S-plus code, find errors, correct and validates output and results.
- Performs complex programming such as data transposition and macros.
- Programs analysis data sets using SAS; combines multiple disparate raw databases and derives analysis variables accurately.
- Uses complicated SAS procedures and options and programs with increasing efficiency.
- Works together with laboratory PI, Collaboration for AIDS Vaccine Discovery (CAVD) and HIV Vaccine Trial network (HVTN) as well as with Duke Human Vaccine Institute statistical cores and laboratories to manage, track and quality control data sets for assays assessing the antibody Fc- mediated functions.
- Interacts with scientists performing the assays and the statistical cores to further develop processes and tools for optimal data analysis of large high content data sets.
- Collaborates with the statistical programming units from the different networks to analyze large data sets.
- Provide feedback to the statistical programming unit and to the investigators or program management as appropriate to refine queries and analyses, developing reports on new data queries as appropriate.
- Drafts statistical sections for study synopses, data summaries and manuscripts.
- Understands the contracted scope of work and forecasts monthly hours expected to complete each trial/project.
- Creates timelines for statistical project management, with assistance from project leader and statistical managers.
- Drafts statistical sections for study synopses and protocols.
- Understands study data and the intricacies of the process through which it is being collected.
- Handles and secures highly confidential and sensitive analyses and documentation.
- Collaborates closely with investigators, sponsors, and other trial leadership to ensure that trial/project results and conclusions are presented accurately and without bias.
- Leads or participates actively in the statistical team responsible for designing and validating analysis data sets, programs, and statistical output products(tables, listings, figures).
- Adheres to standard operating procedures (SOPs) of the functional department as they apply to documentation and validation of clinical research statistics.
- Understands guidelines from FDA, ICH, EMEA, NIH or other regulatory agency as they apply to statistics and programming expectations for each project.
- Collaborates effectively with a variety of types of individuals, programmers, statisticians, research technicians, quality assurance unit, and project leaders.
- Manages project responsibilities with decreasing levels of supervision and takes initiative to complete project specific responsibilities with minimal supervision.
- Demonstrates progress in ability to multi-task.
- Oversees the use of the custom tools for binding antibody multiplex assays.
- Interacts as primary liaison with lab data operations and statistical teams of an off-site collaborator (daily) to resolve data uploads, corrections/modifications and QCs.
- Evaluates system problems, develop and implement corrective action plans.
- Develops and implement systems for data quality control. Implement performance metrics for measuring workflow efficiency and generate work-flow analysis on a per-study and per-technician basis.
- Creates binding antibody data sets from these data in conjunction with the appropriate oversight groups (e.g., the Quality Assurance Unit) to maintain Good (Clinical) Laboratory Practices.
- Maintains and query databases of binding antibody Fc-mediated functions data including all quality control parameters (including Levey-Jennings tracking, preset positivity criteria, and validation data).
- Assists with the implementation of new data queries as requested.
2681 BIOSTATISTICIAN II
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender identity, national origin, race, religion, sexual orientation, or veteran status. ******************************************************* Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job 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.
Work requires a minimum of a Master's degree in (bio)statistics or related field and no relevant experience, or a bachelors degree in (bio) statistics or related field and 2 years relevant experience, or an equivalent combination or relevant education and/or work experience.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE Prior contribution to analysis of research projects, a working knowledge of SAS, and solid command of the English language is required.
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Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job 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.