Company Description: Crescendo Bioscience is a venture-funded molecular diagnostics company providing tools for characterizing and managing diseases in the field of rheumatology, including rheumatoid arthritis. The company applies a comprehensive suite of molecular profiling technologies to discover biomarkers and develop diagnostics that help physicians with the diagnosis, prognosis and treatment of disease.
Position: Senior Director/Director of Statistics
Job Description: Overall responsibility for statistical aspects of clinical study design, algorithm development, health economics assessment, data mining, quality control and product development. Manage statistics group and external consultants. Decision maker on statistical evaluation of clinical trials protocols and will play a key role in this area in interactions with regulatory agencies. Involved in the development of new in silico methods of biomarker discovery for molecular diagnostics. Key interactions with bioinformatics/software development, clinical laboratory, research, process development/automation and clinical groups.
Requirements: The successful candidate will have a PhD in statistics, bioinformatics, biochemistry, biophysics, or a related field and at least 10 years’ experience working in pharmaceutical, molecular diagnostics, or biomedical research. Experience in working in and/or leading multidisciplinary teams, composed of molecular biologists/bioinformaticians, process development and automation scientists, clinicians, and software developers is key as are excellent communication skills. Interest in underlying biology a plus. Experience with the analysis of large datasets is required; the ability to program in a variety of computer languages (R, SAS, others) is a plus. Experience with product development and research in auto-immune diseases preferred.
– Analysis of clinical trial data
– Lead statistical model development for products
– Report to senior management on statistical and model development issues
– Responsible for department budget and goals
– Responsible for working with the clinical laboratory and process development/automation groups to development appropriate QC metrics
– Responsible for the statistical support for commercial laboratory
– Responsible for working with the clinical group on clinical study design
– Responsible for working with research group in design of discovery experiments and evaluation of new technologies.
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