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Statistics Jobs in Australia: 2007 April - June

Rodney Ko, 12 June 2007

Principal Biostatistician

Covance

• 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 Biostatistics' deliverables within assigned projects.
• Develop and coordinate QC procedures for Biometrics deliverables, ensuring activities are appropriate for effectively and efficiently delivering quality output within a specific project.
• Statistical analysis of clinical trial data and related decision making.
• Responsible for statistical input to statistical reports and Clinical Study Reports. Authorises final reports as one of Covance signatories.
• Provide statistical guidance in development of clinical research program and in design of individual studies as part of multi-disciplinary team; responsible for statistical input to protocol; approves protocol as signatory.
• Provide statistical input into design/review of format of CRFs.
• Supervision of less-experienced statisticians within project activities.
• Statistical/Biometrics lead for large global or other major programs.
• Prepare randomisation specifications; generate schedules; verify randomisation components (specification and schedule). Provide input into planning activities related to the preparation of, distribution of and access to randomisation and unblinding information.
• Project management activities for identified projects including financial, resource planning and utilisation, timelines and milestone management.
• Determine documentation requirements for Biostatistics' aspects of projects. Give guidance to support business and regulatory requirements including definition of appropriate documentation, storage/communication media, and retention/return of documents at study close-out.
• Provide statistical input into other disciplines' activities and participate in interdepartmental processes.
• Independent peer review of statistical deliverables, eg, protocols, Statistical Analysis Plans, Tables, Figures and Patient Data Listings, statistical reports, Clinical Study Reports.
• Provision of technical solutions and advice to Covance staff and to clients on statistical methodology and principles.
• Provide support for special committees, eg, DSMBs, including input/review of charters, and ensuring maintenance of appropriate blinding.
• SAS programming and related activities for the presentation and analysis of clinical trial data.
• Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team.
• Contact with client across multiple disciplines.
• Training and development of less-experienced staff within the department.
• Contribution to review and amendment of departmental processes and supporting documentation.
• Contribute to proposal activities and client presentations.
• Represent the department during audits.
• Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP.
• Perform other duties as requested by management.