CardioVascular BioStatistician - PA

Pennsylvania  ‐ Onsite
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Keywords

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
Start date
02/2014
Duration
12 Months
From
Real Staffing
Published at
11.01.2014
Project ID:
649290
Contract type
Freelance
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