Senior Manager, Biostatistician Consultant

• 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
• Support of Business Development, by actively contributing to study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings
• 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 (e.g. discussing analysis concepts, presenting and discussing study results)

• PhD or MS in Statistics or related discipline with substantial experience
• Good analytical skills
• Good project management skills
• Professional attitude
• Attention to detail
• Thorough understanding of statistical issues in clinical trials
• Ability to clearly 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 SAS programming required
• Ability to work independently
• Good mentoring/leadership skills
• Good business awareness/ business development
• Competent in written and oral English in addition to local language

The knowledge of pharmacokinetic data is an advantage

• Patient-led in everything we do
• Supportive and inclusive environment
• Opportunities for career growth
• Flexible work arrangements
• Diverse therapeutic areas and project exposure
• Advanced Technology