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The Division of Epidemiology, Biostatistics and Preventive Medicine, within the Department of Internal Medicine at the University of New Mexico is seeking a Biostatistician for the UNM Statistics and Data Coordinating Center to support multisite clinical trials.
1. Provides statistical support to assigned clinical trials or scientific research projects.
2. Works with SDCC leadership and study investigators to design clinical trials or clinical research studies, write statistical analysis plans, perform sample size estimation, and develop reporting specifications for protocols and/or grant proposals.
3. Provides solutions and responses to statistical issues arising in regulatory, quality, and compliance.
4. Reviews and provides analysis of safety reporting, biomarker analyses and other aspects of clinical trial monitoring including recruitment, retention, study status, AEs, etc.
5. Assists in preparation of clinical trial documents, including clinical protocols, investigator brochures, statistical analysis plans, etc., as needed.
6. Assists in the preparation of clinical study reports, scientific abstracts, peer-reviewed manuscripts, and grant proposals.
7. Works with SDCC leadership and principal investigators to handle requests from regulatory agencies, local IRB and ethical committees, and other health authorities.
8. Interacts with team members across functional areas and multiple studies.
9. Ensures timeliness, regularity, and high quality of deliverables.
10. Supports staff to resolve statistical or technical issues (e.g., database-related issues).
11. Interacts with external collaborators and statistical consultants.
12. Attends regularly scheduled and ad-hoc meetings as requested.
13. Performs miscellaneous job-related duties as assigned.
1. MS or PhD in Statistics, Biostatistics, or closely related field.
2. At least seven years of directly related experience (preferred experience will be from a CRO, biostatistics shared resource, or clinical trials unit).
3. Experience working as a statistician/statistical programmer in clinical trials and medical research.
4. Effective communication with scientific investigators about the design, analysis, and results of clinical trials or other medical research studies.
5. Experience applying advanced statistical models such as generalized linear models including mixed models, and survival analysis.
6. Experience contributing to clinical trial documents including clinical protocols, investigator brochures, statistical analysis plans, and DSMB reports.
7. Proficiency in planning, creating, programming and managing complex statistical computer databases such as REDCap.
8. Experience using SAS (including macros and SQL) and other statistical software such as R.
9. Familiarity with data management principles and regulatory requirements for clinical trials and medical research.
10. Effective communication, orally and in writing, with collaborators from various backgrounds including clinicians, bench scientists, project managers, data collectors, and other scientists.
1. Master's degree; at least 3 years of experience directly related to the duties and responsibilities specified.
2. Completed degree(s) from an accredited institution that are above the minimum education requirement may be substituted for experience on a year for year basis.