Principal Biostatistician

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 7+ 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