Senior Biostatistician
Bengaluru, India 求人ID R0000025095 Category Biostatistics JobsAbout this Role
Job Purpose:
The Principal Biostatistician works independently on all level complexity clinical trial projects, often with major regulatory impact. The person will be recognized internally and externally as a statistical expert.
Operational Execution
- Provide broad statistical support, including trial design, protocol and CRF development on specific studies
- Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
- Perform sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols
- Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans
- Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review
General Activities
- Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis .
- Understand, apply and provide training in extremely advanced and sometimes novel statistical methods
- Contribute to the development and delivery of internal and external statistical training seminars and courses
- Review position papers based on current good statistical practice
- Interact with clients and regulatory authorities
- Review publications and clinical study reports
- Travel to, attend and actively contribute to all kind of client meetings as appropriate (Ee discussing analysis concepts, presenting and discussing study results)
- Additional responsibilities as defined by supervisor/manager.
Knowledge and Experience:
- PhD or MS in Statistics or related discipline with substantial experience around 6+ Years
- The knowledge of pharmacokinetic data is an advantage
- Competent in written and oral English in addition to local language
Education:
- PhD in Statistics or related discipline, MS in Statistics or related discipline
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