Senior Director, Biostatistics & Bioinformatics
The Director or Senior Director, Biostatistics & Bioinformatics is responsible for establishing the analysis of end points for pilot studies and guiding the development of clinical diagnostic programs. The position will involve interacting directly with the clinical collaboration team, the Chief Medical Officer, and external collaborators to establish project goals which the informatics team can efficiently execute. This individual will also perform literature searches in particular program areas to help guide project level goals and educate the project and informatics teams. As projects move from pilot studies to diagnostic development projects, this person will oversee the transition into development. This position supervises the work of a small group of Analysts. Level is commensurate with experience.
Key Job Responsibilities
- Supervise and mentor a small team of data analysts and model builders who develop cutting edge statistical methods for “big data” biomarker discovery and diagnostic predictions
- Provide biostatistical/epidemiological input for the design of new studies, and create appropriate analysis plans
- Provide direction to all stakeholders on suitable risk/benefit trade-offs and promote appropriate creativity during the different phases of discovery, verification, development and commercialization of biomarkers and diagnostics
- Improve utility of deliverables and provide transparency on interim analysis through clear direction and robust process
- Acquire disease-specific knowledge through literature, discussions with key opinion leaders, and meetings; distill that information down for the project and informatics teams
- Provide biostatistical/epidemiological support for academic collaborations with key opinion leaders, including writing study design and statistical analysis plan sections for grant proposals
- Provide study designs and guidance for quality control and development teams
- Assist in statistical/epidemiological analysis of clinical collaboration and development projects
- Work with the clinical collaboration team to identify clinical sample sets needed to achieve analysis and project goals
- Oversee clinical data base operations, including curation and importing of meta data for clinical studies
- Support development of diagnostic products and assist in regulatory filings
Skills & Requirements
Education
Master’s degree or Ph.D. in Biostatistics, Epidemiology or related field
Skills and experience
Required:
- 5+ years managing of highly-technical teams
- Excellent verbal and written communication skills
- Solid background in theoretical and applied statistics/epidemiology including robust and non-parametric techniques
- Expertise in performing both routine and exploratory statistical analyses (e.g., regression, ANOVA, survival analysis) in R or related software packages
- Experience in techniques relevant to high-dimensional data (e.g., biomarker discovery, machine learning, electronic medical records, etc.)
- Detail-oriented pro-active working style capable of both self-directed independent work and participation in inter-disciplinary teams
Desired:
- Experience in molecular diagnostic development
- Experience working with genomic or proteomic signals
- Experience in the analysis of high dimensional biological data and biomarker identification
- Experience with FDA molecular diagnostic submissions