- Provides input to project teams including trial design, sample size estimation, randomization, and statistical methods.
- Responsible for statistical sections of protocols, statistical analysis plans, analysis of study data, and assists in interpretation of study results. Collaborates and works closely with clinical operation team and regulatory affairs team for premarket Approval applications to the regulatory authority.
- May directly supervise Biostatisticians to support internal project teams and regulatory requirements. Contributes ideas for more efficient and effective design and analysis of internal and external study programs.
Main Tasks & Responsibilities :
- Designs studies needed to establish sensitivity, specificity, reproducibility, comparability and clinical utility claims; creates statistical analysis plans, data analyses, and contributes to and collaborates in the preparation of clinical protocols and study reports.
- Maintains expertise in state-of-the-art data manipulation and statistical analyses through research and continuing education.
- Assesses and implements statistical analysis programs in support of product development and approval.
- Works with external partners, including pharmaceutical companies, to design and assist in execution of appropriate studies in support of regulatory submissions.
- Monitors work of self and service provider to ensure Quality, and continuously promote Quality First Time.
- Manages day-to-day operational aspects of multiple projects.
- Develop local data management related SOPs according to the requests of Dia Symphony, Divisional Standard, Guideline and GCP；
- To be window person of MRA biostatistics to other functions, handle inquiring and feedback; provide active and strong technical supports to internal or external as needed. keep smoothly interaction with global DM team.
- Develop and maintain a good working relationship with other functions, to support the clinical projects.
- Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection
Basic Requirements of the Job:
- Masters degree in Statistics or a related field. Preferably in biostatistics.
Knowledge of CFDA guidelines for in vitro diagnostic devices and the required statistical basis for sensitivity, specificity, agreement rates, reproducibility testing and clinical evaluation required for validation and CFDA clearance and approval.
- Familiarity with regulatory and ICH-GCP guidelines applicable to biostatistics.
- Strong ability to collaborate across departments and interact with various levels in the organization.
- High attention to detail with skill in producing organized reports.
- Ability to write statistical code and documentation.
- Ability to work in a team-focused environment is essential, as all statistical analyses under design control require both lead & coordinate statistical analysis and quality control (QC).
- Participates in the development and implementation of novel statistical methods to increase efficiencies and likelihood of successful product commercialization.
- Proficiency in both spoken and written English.
- Maintains broad knowledge of state-of-the-art statistical methods.
- Ability to work under time pressure while maintaining high standards of precision and quality.
- Ability to prioritize multiple projects.
- Comprehensive understanding of the clinical study process.
- Excellent communication and interpersonal skills.
- At least 5 years of relevant experience. Significant experience in analysis and reporting using statistical software（ SAS ,etc.）. Preferred: experience in CFDA submissions and in vitro diagnostic tests.
- Biostatistics experience in Global pharmaceutical companies, Medical Device companies, Clinical Research Organization, Business Process Outsourcing companies.
- Design of Experiments (DOE) experience and Biostatistics management procedure development experience is preferred.
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