| Title: PK/PD Programmer
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| Location: New London, CT
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| Job Type: Contract
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| Compensation: per Hour
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| Reference Code: 951222-AQG
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Description: Our client is seeking a Senior Level Statistical Programming Support for PK/PD Programming and Full Development Support.
Service Areas may include:
Program Development:
- Set up and run data extraction programs
- Program figures, tables, and listings
- Create Physical data Model Document
- Create mock tables
- Develop, test, and validate programs to produce figures, tables, listings, data mappings and extracts
Quality Control (-QC-):
- Review top line reports specifications
- Develop QC Programming Plan
- Perform QC of published tables, SAS datasets, and algorithms
- Produce QC documentation
Production of Tables, Listings, Figures, and datasets:
- Produce reporting datasets
- Produce tables and analyses for all reporting events for all data (including PK concentration parameters) for a Study
- Issue draft/blinded tables
- Issue protocol deviations
- Produce and issue final tables
- Produce Electronic Submission (ESUB) components
Interim Analyses:
- Provide input to or review interim analyses plan
- Produce tables, listings, figures, and datasets for interim analysis
PK/PD dataset Production:
- Review specifications for PK/PD data file
- Develop and perform QC on PK/PD data file
- Produce and perform QC on draft tables
- Produce tables
- Deliver pre-specified, QC'd datasets to the PK clinical group for further analysis
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Requirements: Minimum Role Requirements:
- Experience of extracting, manipulating, summarizing, analyzing and presenting data using SAS procedures
- Experience of SAS/MACRO, SQL and SAS/BASE procedures
- Experienced in use of SAS/GRAPH and Statistical procedures
- Experience of Clinical data and medical dictionaries
Role Responsibilities May Include:
- Create submission-ready standard data presentations and data sets using standard coding and following OPD processes including SDLC
- Conduct interim analysis, QC, eSub wor, as required
- Understand and plan work to delivery timelines including allowing time for internal FSP QC, as appropriate
- Work with supervisor to balance conflicting priorities
- Understand timelines for and milestones affecting their work and alert supervisor to potential slippage
- Ensure training done before embarking on a task
- Alert supervisor and PoC where skills or knowledge are not adequate for the task set - seek help
- Develop appropriate QC programs as defined at kick-off or by PoC
- Run routine QC programs
- Carry out rework as requested by supervisor, PoC
- Follow escalation process and neither suppress nor over-escalate issues
- Contribute to close-out evaluations and any discussion
- Ensure updates to action / progress logs are completed in a timely fashion
Please use the apply online option!
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