Position Summary:

The Director will establish and lead the Biostatistics and Clinical Data Management organization within the Company's Clinical Development Group, working closely with the clinical project teams and with the Assay R&D, Medical Affairs and Regulatory Affairs functions.

Responsible for all relevant deliverables, from planning through to the final work product, including:

• Optimization of algorithms for clinical biomarker panels during early development
• Statistical Analysis Plans (SAPs)
• Data and analysis sections of clinical study protocols and reports
• Data Management Plans (DMPs)
• Interim and Final statistical analyses and reports
• Work closely with other clinical personnel to develop and implement effective methods for analysis and QC of clinical results
• Review and sign off (for the biostatistics and clinical data management function) on clinical study reports and other regulatory documentation
• Ensure scientific integrity of statistical methodology used in all projects
• Ensure that externally contracted biostatistics and clinical data management projects are delivered on time, on budget, and at the expected level of quality

Preferred Educational Background:

• A graduate degree in Biostatistics or a closely related discipline is required; a PhD is highly preferred
• Post-graduate specialization in clinical trial statistics would be a plus
• A minimum of 10 years (minimum 5 years, if doctoral level) of experience in the areas of biostatistics and clinical data management required, in the medical device and/or pharmaceutical industry
• Proven experience with clinical trials for in vitro diagnostics (IVD) products highly preferred
• A minimum of 5 years of supervisory experience required
• Solid knowledge of ICH, ISO, GCP and FDA guidelines/regulations required
• Previous experience in managing CROs is highly preferred
• Ability to articulate complex statistical concepts verbally as well as in writing
• Strong collaboration and influencing skills, both internally and externally
• A positive attitude and a sound work ethic
• Ability to work well in a team