Senior Biostatistician
Job Description
As a Senior Biostatistician at Freenome, you will be responsible for statistical activities supporting Freenome’s clinical validation studies and contribute to our scientific and clinical studies and publications. The Senior Biostatistician will perform scientific statistical analyses in support of clinical trials. The position will work collaboratively with the clinical and regulatory teams in designing clinical trials and developing the statistical analysis plan, facilitating the implementation of statistical analyses, providing statistical input to the Clinical Study Report and scientific presentations/manuscripts.
You will interface with clinical therapeutic area members, clinical data management, clinical operations, medical writing and other functions. This position will also participate in managing vendors to ensure quality of all deliverables and adherence to requirements/timelines.
This role reports to the Chief Medical Officer.
Responsibilities
- Partner cross-functionally with Research, Development, Clinical, Regulatory, Quality, and Scientific and Medical Affairs in order to develop study designs.
- Contribute to study protocols/SAPs and determine appropriate statistical methodology.
- Participate in database design meetings to ensure that the data collected are in high quality and satisfy analysis requirements.
- Collaborate with the statistical programming staff to ensure that all programs meet analysis and external requirements. Work with programmers to provide tables, listings and graphs, including ad hoc validation.
- Analyze data and interpret results from clinical trials to meet objectives of the study protocol. Independently apply and implement basic and complex statistical techniques to these analyses. Conduct ad hoc analyses if applicable.
- Generate data in support of abstracts, poster presentations and publications.
- Prepare oral and written reports to effectively communicate results of clinical trials to the project team and corresponding parties.
- Provide statistical input through the planning and conduct of clinical trials with departments with Freenome as well as with external vendors.
- Make recommendations or resolve technical, quality, and timeline issues.
- Generate statistical materials supporting communications with regulatory agencies as part of regulatory submissions.
- Generate statistical materials to aid communications with regulatory agencies as part of regulatory submissions and design history file documentation.
- Contribute to the computation of power calculations and statistical modeling, including code generation, audit and validation.
Job Requirements
- Ph.D. or Master’s in statistics, biostatistics, or related scientific field with a minimum of four years of relevant experience.
- Hands-on experience in medical device development, drug development, and regulatory submissions.
- Demonstrated knowledge, proficiency, and hands-on application of statistical techniques with an emphasis on applications to the field of medical diagnostics or drug development.
- Strong understanding of clinical trial analysis and study design, including regression analysis, case-control study design, basket trial design, and subgroup analysis.
- Solid understanding of quality requirements for biostatistics, programming, and data management.
- Solid understanding of best practices and GxP strategies supporting product development and submissions to regulatory agencies.
- Excellent written and verbal communication as well as data visualization skills.
- Ability to manage multiple projects and priorities simultaneously.
- Strong programming skills in R and/or Python.
- Proficiency on modern statistical methods, such as treatment effects and causal modeling.
- Proficiency with MS Office and Google Suite.
- Proficiency with working in cloud computing environments such as Google Cloud Platform.
