Penfield Search Partners
Our client is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. Their proprietary platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum and aims to address the needs of early-stage cancer patients with early detection. In this role you will be part of a team in the late scientific stages of making breakthrough medical diagnostics available for patients. You will support the adoption of new cancer screening technologies by designing studies to validate their performance leading to regulatory approvals. This is a real opportunity to gain experience in pivotal cancer screening clinical trials, gain familiarity with the diagnostic environment and to co-operate with team members in major clinical trials and smaller scale real world evidence projects.
You will be responsible for the following statistical activities that support clinical trials:
- Overseeing study design
- Authoring statistical sections of the study protocol/clinical study report
- Drafting associated analyses into the Statistical Analysis Plan (SAP)
- Reviewing/interpreting results of the data generated from the study
- You will be a subject matter expert in biostatistics, data analysis and study design for the full team that includes Clinical Operations, Regulatory Affairs, QA, Software Engineering, external partners, and regulatory agencies.
Essential Duties and Responsibilities:
- Provide statistical input to study design, protocol development, sample size calculation, care report form, interpretation of study results, clinical study report and on addressing questions from regulatory agencies
- Develop and maintain Statistical Analysis Plans (SAPs) that include derived variables and templates of tables, listings and figures
- Collaborate with statistical programmers, biostatisticians, clinical operations, data managers, regulatory affairs and project management to meet project timelines and deliverables
- Work to develop presentations for internal/external stakeholders
- Support a variety of statistical programming activities
Qualifications:
- D. in Biostatistics and 3+ years of relevant experience with experimental design and associated statistical analyses (e.g. hypothesis testing, regression and method comparison). Strong MS-level candidates will be considered as well.
- Strong problem-solving skills and able to identify issues and investigate causes independently to formulate solutions
- Familiarity with method comparison analyses such as Deming regression and the variety of non-parametric methods
- Familiarity with time-to-event data and the corresponding statistical methods (ie. Kaplan-Meier method, Cox proportional hazards regression, etc)
- Experience with SAS statistical programming
- Experience with or capability to learn R
- Able to work independently and in a collaborative environment
- Able to communicate effectively with cross-functional teams and to work in both small and large working teams
- Ability to multi-task and interface with team members who are working under deadlines; ability to set priorities and excellent time management skills
- Have the curiosity in improving statistical methods and practices in support of cancer screening