Description
New Contract Opportunity!Biostatistician - Cardiovascular
Major PharmaceuticalKing of Prussia, PA
12 month Contract
Seeking a statistician for a contractor position for 12 months with significant responsibilities in overseeing the activities of a CRO in a fully outsourced model of drug development.
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.
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 (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)
- 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.
Please send me an updated resume ASAP. REFERRALS WELCOME.
Thanks
Paul Dai
To find out more about Real please visit www.realstaffing.com