Responsibilities:

• Coordinate biostatistical aspects of submissions to regulatory authorities; participate in presentations to regulatory reviewers.
• Provide training on biostatistics-related topics to other disciplines.
• Supervision of less-experienced biostatisticians within project activities.
• Biostatistics lead for large global or other major projects.
• 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 Biostatistics deliverables, ensuring activities are appropriate for effectively and efficiently delivering quality output within specific project.
• 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 company 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.
• Determine documentation requirements for Biostatistics aspects of projects.
• Independent peer review of statistical deliverables, e.g., protocols, Statistical Analysis Plans, Tables, Figures and Patient Data Listings, statistical reports, Clinical Study Reports.
• 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.
• Contact with client across multiple disciplines.
• Contribute to proposal activities and client presentations.

Requirements:

• Must have MS or PhD in Statistics.  No other degrees acceptable.
• Minimum 8-10+ years exp.
• Minimum of 1 year of CRO experience as a Project Lead required
• CDISC and AdAM experience required
• The ability to work to tight deadlines while maintaining high standards.
• SAS proficiency including use of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data and survival analysis
• Ability to adhere to strict guidelines and codes of practice
• A good knowledge of the overall Clinical Trial process and of its application within Clinical Development.
• Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc., across a variety of trials.
• Ability to explain statistical concepts to non-statisticians.
• Supervisory and organizational skills.