Regional – Biostatistician

EM-R-Biostat-1101

Clinical Research

USA, Germany

Duties and Responsibilities:

The Biostatistician Acts as lead statistician on projects of moderate to large size and complexity; support lead statistician on very large, complex studies. May have staff management and/or project management responsibilities. Also, writes statistical reports. Aid in the development of protocols.

• Provide statistical input into other disciplines’ activities and participate in interdepartmental processes.
• Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team. Include P&L, Revenue and/or Budget responsibilities (if applicable)
• Assigned tasks related to the development of less-experienced staff within the department.
• Responsible for development of Statistical Analysis Plans, to include statistical methodology, statistical programming procedures, definition of derived variables, data–handling rules and mockups.
• Responsible for Biometrics deliverables within assigned projects.
• Perform QC of all efficacy and safety datasets and data displays.
• Statistical analysis of clinical trial data and related decision-making.
• Responsible for statistical input to statistical reports and Clinical Study Reports. Authorizes final reports as one of ESTERN Medical signatories.
• Provide statistical representation on multi-disciplinary team preparing protocol; responsible for statistical input; approves as signatory.
• Provide statistical input into design/review of format of CRFs.
• Prepare randomization specifications; generate schedules; verify randomization components (specification and schedule). Provide input into planning activities related to the preparation of, distribution of and access to randomization and unblinding information.
• Take responsibility for overall status and quality of Biostatistics’ project documentation, including maintenance of hardcopy and electronic files.
• Independent peer review of statistical deliverables, eg, protocols, Statistical Analysis Plans, Tables Figures and Patient Data Listings, statistical reports, Clinical Study Reports.
• Provide support for DMCs, ensuring maintenance of appropriate blinding.
• SAS programming and related activities for the presentation and analysis of clinical trial data.
• Contribute to review and amendment of departmental processes and supporting documentation.
• Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management.
• Provision of technical solutions and advice to ESTERN Medical staff and to clients on statistical methodology and principles.
• Contribute to proposals activities and client presentations.
• Contact with client across multiple disciplines.
• Represent the department during project-driven client audits.
• Carry out all activities according to appropriate ESTERN Medical SOPs, working within the framework of the Quality Management System and to GCP.
• Perform other duties as requested by management.
• English Written & Verbally

Education/Qualifications

• Masters or PhD in Statistics or related field

Experience

• 5 years experience in pharmaceutical or CRO industry