Description
Key Candidate Qualifications:The successful candidate must have extensive experience in cardiovascular drug development and will ensure that statistical methodology and analyses proposed by the vendor are methodologically rigorous, allowing for robust phase 2 and 3 decision making acceptable to key regulatory and academic stakeholders.
The successful candidate must have experience in overseeing the activities of a large CRO in every aspect of a large cardiovascular program.
The successful candidate must work as a team member in a multidisciplinary sponsor/academic /CRO environment to identify and solve problems arising in the life of the project.
The successful candidate must work as a team member in a Sponsor collaborative environment with data managers, medical writers and epidemiologists.
Description of Duties:
Strategic Planning
- Acquire detailed understanding of study design, execution and analysis of Sponsor Phase 2 and 3 cardiovascular studies with respect to objectives and the statistical implementation of those objectives with respect to:
- Development (with data management) of a quality oversight plan
- Critical Review of Study, DSMB, and integrated SAPs
- Critical Review of statistical basis for risk-based central/site monitoring
- Review and approve key study documents (SAP, charters, CSR)
Study Oversight:
- Interfaces with the DSMB and CRO main study statistician as needed to achieve quality oversight.
- Routinely monitors study progress against quality plan, identifying issues and providing solutions when plan is not being met
- Ensures that tracking reports provided by vendor meet key performance measures
- Attends study team meetings (every 2 weeks)
- Acts as ad hoc sponsor at central operations committee meetings, (with clinical and clinical operations leads) Steering Committee and DSMB meetings
- Ensures (with the clinical team) that data displays are clinically meaningful and appropriate.
- Identifies and designs in-text tables for direct insertion within the CSR without major reformatting
- Reviews TFLs as a member of the sponsor study team.
- Ensures that quality deliverables from other biometric functions (e.g. data management, clinical programming, IVRS) are provided by vendor(s)
- Ensures data consistency between listings and summary tables by reviewing table validation plans and performing validation checks as needed.
- Ensures that datasets are provided in regulatory submission format, particularly ADaM datasets
- Ensures that eCRF design meets the requirement for cardiovascular endpoint trials
- Independently confirms validity of key primary study variables
- Performs post hoc analyses as needed . To meet the requirements of this objective, the candidate must have substantial experience with SAS and at least one graphics package such as SAS/GRAPH, JMP or R.
To find out more about Real please visit www.realstaffing.com