The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research and education. The Biostatistician / Research Data Analyst will provide statistical support for clinical research projects, collaborate with faculty, and contribute to the design and analysis of clinical trials, particularly in tuberculosis research.
Responsibilities
- Drafting sections for trial protocols pertaining to statistics
- Providing statistical support for data capture forms (case report forms, CRFs) and database specifications for the trials
- Drafting the statistical analysis plan
- Contributing to study standard operating procedures (SOPs)
- Responding to queries from collaborators on statistical issues
- Joining team and project meetings
- Writing code for data analysis
- Performing interim data analyses for reporting to Data Safety and Monitoring Boards (DSMBs)
- Providing regular reports for reports to funders and other stakeholders
- Performing final analyses at trial completion
Skills
- Master's degree in Biostatistics (or a closely related subject) or PhD in Biostatistics (or a closely related subject), or Bachelor's degree in Statistics/Biostatistics with substantial relevant experience in clinical trials work
- At least 1 year of practical work experience in clinical trials or related work
- Human Subjects research training or ability to obtain in the first year of employment
- Thorough knowledge of research function
- Thorough skills associated with statistical analysis and statistical methodology
- Thorough understanding of statistical aspects of randomized clinical trials
- Skills to communicate complex information in a clear and concise manner both verbally and in writing
- Knowledge of statistical programs including R or Stata (R strongly preferred)
- Contributions to peer-reviewed publications in scientific journals and/or grant applications
- Ability to take on responsibility for the day-to-day management of statistical aspects of a project
- Ability to work effectively in a multi-disciplinary team
- Attention to detail
- PhD in Biostatistics (or a closely related subject)
- Experience working in or with the pharmaceutical industry, or in clinical research conducted under the auspices of a stringent regulatory authority
- Familiarity with standards for clinical trials including ICH GCP, FDA or EMA requirements, CONSORT, SPIRIT, etc
- Research skills at a level to evaluate alternate solutions and develop recommendations
- Knowledge of medical terminology with a focus on tuberculosis
- Experience with Quarto and Markdown for reproducible reporting of statistical analyses
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