Clinical Research

• Manage and oversee customer relationships on a project level.
• Act as the Lead biostatistician and primary biostatistician contact with the sponsor at the project level.
• Has overall accountability of quality, appropriateness and correctness of biostatistician deliverables.
• Responsible for biostatistics project management (timelines, scope, budget, resourcing) on a project or program level.
• Write Statistical Analysis Plans (SAPs) for clinical trials.
• Development of SAS programs for study TLFs, based on the study SAP and shells.
• Provide training/mentorship to statisticians.
• Generate randomization schemes.
• Represent clients at regulatory meetings.
• Provide guidance on study design and statistical methodology during protocol development.
• Review statistical output produced by the statistical programming team.
• Review statistical documentation produced by other statisticians.
• Review the Clinical Study Report (CSR) for appropriateness of statistical methodology described, results reported and conclusions stated.
• Follow the appropriate Standard Operating Procedures (SOPs) for all biostatistics-related activities.
• Ensure that all activities comply with Good Clinical Practices (GCP) standards.

Principal Biostatistician

Clinical Trial Manager – Sponsor Dedicated