18 set - Milano
ALFASIGMA
The Senior Director, Biostatistics Lead is responsible and accountable for biostatistics as it relates to all stages of clinical development for one or more therapeutic areas delivering clinical studies and research programs of the highest quality in a time and cost-effective manner.
The Senior Director, Biostatistics Lead ensures the successful strategic planning and execution of all therapeutic area biostatistics activities using both internal and external resources. Provides input into clinical development plans, protocols, clinical study reports, regulatory submissions, abstracts, and manuscripts to ensure that statistical elements are in line with the overall product strategy. This position may represent biostatistics providing subject matter expertise on the clinical development teams across the company’s portfolio,
In partnership with other leaders of the global biometric sciences department and the global Head of Biometric Sciences, the Senior Director, Biostatistics Lead, is expected to provide input for cross functional harmonization and standardization,
technology and process improvement, CRO oversight and resource and budget forecasting and monitoring.
Principal Accountabilities
The Senior Director, Biostatistics Lead within the GBS, Biostatistics department, should be able to perform each of the following satisfactorily:
- Assume accountability for biostatistical components of regulatory submissions; ensure activities are conducted in compliance with relevant regulatory requirements.
- Provide biostatistics subject matter expertise to the clinical development teams as appropriate; Liaise with non-clinical and pre-clinical teams regarding the conduct of experiments, statistical methodology, data analysis and interpretation, and regulatory issues.
- Lead and supervise an efficient and effective biostatistics team. Manage performance of direct reports, ensure development and succession planning. Provide coaching and feedback to foster professional developm
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