Principal Biostatistician

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