Essential Duties and Responsibilities*
- Oversee study level tasks from a statistics perspective including: participate in study design and sample size determination, author/review statistics section of the protocol; author/review SAP and other biostatistics related study documents.
- Provide sponsor oversight to the CROs on the study level activities by providing guidance on statistical matters and ensure consistency across studies.
- Ensure statistical integrity of study deliverables (by CRO or internal); Review and sign off on the key documents, including SAP, mock shells, data derivation specification, CRF, CRF completion guidelines, etc.
- Coordinate with SAS programming staff to perform sponsor quality control of study level deliverables.
- Identify risks/gaps from study level activities and work within the biometric team and/or cross-functional teams to resolve or follow up.
- Be the statistical point of contact for Esperion for assigned