Biostatistician / Research Data Analyst

University of California San Francisco•San Francisco, CA

2d•Remote

About The Position

The Biostatistician / Data Analyst will be providing statistical support for ongoing clinical research projects, working on statistical methodological projects, and performing data analysis from multi-center randomized controlled trials, working closely with the PI, Dr. Phillips (https://profiles.ucsf.edu/patrick.phillips). The work will cover one or more research projects. The biostatistician will also collaborate with other faculty in the UCSF Center for Tuberculosis. Current major projects are as follows: Statistical activities that are part of the trials for the UNITE4TB consortium – a public-private partnership conducting phase II trials of new regimens for the treatment of tuberculosis (https://www.unite4tb.org/). Application of Bayesian methods for evidence synthesis for clinical trials to inform WHO guidelines for the treatment of TB. Adaptation of methods for generalized pairwise comparisons (including DOOR, hierarchical outcomes, net benefit, win odds and win ratio) to TB clinical trials and specifically to supplement results in the context of non-inferiority of an efficacy outcome. Responsibilities of the Biostatistician include 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, and performing final analyses at trial completion. In all these activities, the biostatistician will work closely with Dr. Phillips. The Biostatistician will join an existing team of Masters-level and PhD-level biostatisticians within the UCSF Center for TB Biostatistics Core working on tuberculosis clinical research projects, led by Dr. Phillips (https://tb.ucsf.edu/biostatistics-core). The biostatistician will have the opportunity to attend biostatistics webinars (and other training activities) organized by the Department of Epidemiology and Biostatistics. The Biostatistician will be part of multi-disciplinary project teams involving study coordinators, clinicians, data managers, pharmacists, and others both within UCSF and at collaborating institutions in the US and globally. Most studies are based internationally with collaborators in the US as well as in Europe, Africa, and East Asia. The Biostatistician may be required to undertake domestic or international travel for study site visits and conference attendance, depending on job requirements and grant funding availability. The Biostatistician will also have the opportunity to undertake statistical methodological work. The focus of the methodology will be to address specific aspects in the ongoing projects, particularly clinical trials to improve the diagnosis and treatment of tuberculosis, the world’s deadliest infectious disease. The post-holder will initially receive close support and supervision while increasingly taking responsibility for organizing and managing their own workload independently. Mentoring for career development will be provided by Dr. Phillips. The post holder will contribute to publications and grant applications (for both clinical and statistical projects). They will have an opportunity to write their own first-author publications or contribute to publications as an author based on their own work or collaborative work within their projects. The post holder is expected to develop their knowledge of the biology and epidemiology of relevant disease areas by reading relevant journals, attending journal clubs, conferences, etc. The post holder may undertake the work fully or partly remote with some flexibility in working hours, although the UCSF Center for TB Biostatistics Core strongly advocates an appropriate work-life balance. The post-holder must be located within the US. The final salary and offer components are subject to additional approvals based on UC policy. Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement. The salary range for this position is $90,700 - $193,500 (Annual Rate). To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

Requirements

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

Nice To Haves

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
Human Subjects research training or ability to obtain in the first year of employment

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
Contributing to publications and grant applications