Job Description

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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