Informatics | San Francisco, Ca | Full Time
The Biostatistician is a key position responsible for leading the planning and execution of statistical analyses related to ongoing and upcoming projects and clinical trials. The Biostatistician will interface with the Clinical Development team to advise on study design (including sample size calculations and endpoints) and cohort selection, and with the Informatics team to assist in data analysis. As available, this individual will also assist with the statistical analysis of other Parker Institute R&D efforts, including helping with deep immune profiling (>10 high-dimensional biological assays) of patients undergoing cancer immunotherapy treatment. In all job functions, the Biostatistician is expected to bring a high degree of statistical rigor and attention to detail.
Reporting Structure and Team
The Biostatistician reports to the VP, Informatics and is a key member of the Informatics team.
Essential Job Functions
- Provide statistical expertise and input to drug development programs, including the reporting of interim and final study results, specification and generation of tables, lists and figures, and analyses requiring advanced statistical methodologies
- Contribute to written reports such as the clinical study report and help answer questions from health authorities (e.g. FDA, IRBs, other regulatory agencies)
- Collaborate in the process of protocol development by:
- Choosing an appropriate study design, including statistical methodologies
- Calculating necessary sample size to achieve a pre-specified power
- Writing the statistical section of the protocol
- Generate tables and listing to provide study updates to collaborators
- Assist on exploratory data analyses for PICI investigators and scientific staff
- Author, develop and implement timely and consistent execution of statistical analysis plans for multi-site clinical trials
- Work closely with lead statisticians at the 6 PICI academic centers
- Provide statistical support for mechanistic assay development team
Knowledge, Skills, and Experience
- M.S. in biostatistics or equivalent experience
- Experience running early-stage clinical trials (Phase I/II)
- Excellent knowledge of statistical theory including experimental design, categorical data analysis, analysis of variance, survival analysis, and non-parametric methods.
- Proficiency in SAS and R, Python a plus
- Ability to understand scientific questions and formulate appropriate statistical methods to test them.
- Ability to work in a start-up environment
- Good verbal and written communication skills
- Effective collaborator and team player
- Experience working with biomarker data from high-dimensional molecular assays, such as flow cytometry and next-gen sequencing (preferred)
- Familiarity with regulatory and research guidelines on drug development, GCP and statistical principles including ICH guidelines (preferred)
- Familiarity with CDISC, SDTM, and ADaM (preferred)