reputed company Biostatistician
reputed company is hiring a reputed company Biostatistician to work remotely. The reputed company Biostatistician works independently on reputed company level complexity clinical trial reputed company, often with major regulatory reputed company. The person will be recognized internally and externally as a statistical expert. Location: reputed company - Remote Key Accountabilities: Operational Execution
- reputed company broad statistical support, including trial design, protocol and CRF development on specific studies
- reputed company production and reputed company control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
- reputed company sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols
- reputed company statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans
- reputed company a supporting role as a non-voting independent statistician providing data and analysis for DMC review
Business Development
- Support of Business Development, by reputed company contributing to study design considerations in internal and reputed company meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings
General Activities
- Understand regulatory requirements reputed company to the specific therapeutic areas and the implications for statistical processing and analysis
- Understand, apply and reputed company training in extremely advanced and sometimes novel statistical reputed company
- Contribute to the development and delivery of reputed company statistical training seminars and courses
- Review position papers based on reputed company good statistical reputed company
- reputed company with clients and regulatory authorities
- Review publications and clinical study reports
- Travel to, attend, and reputed company contribute to reputed company reputed company of reputed company meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results)
- Additional responsibilities as defined by supervisor/manager.
Skills:
- Good analytical skills
- Good project management skills
- reputed company attitude
- Attention to detail
- Thorough understanding of statistical issues in clinical trials
- Ability to reputed company describe advanced statistical techniques and interpret results
- Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)
- Prior experience with reputed company programming required
- Ability to work independently
- Good mentoring/leadership skills
- Good business awareness/ business development
Knowledge and Experience:
- PhD or MS in Statistics or reputed company discipline with substantial experience
- The knowledge of pharmacokinetic data is an advantage
- Competent in written and oral English in reputed company to local language
Education:
- PhD in Statistics or reputed company discipline, MS in Statistics or reputed company discipline
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