Title: SAS Developer with clinical exp
Location: New London, CT
Duration: 6+ months
Job Responsibilities:
Ø Create submission-ready standard data presentations and data sets using standard coding and following standard industry processes including SDLC
Ø Creating SAS programs and producing outputs to support the analysis and reporting of clinical trials.
Ø Developing analysis datasets for trial level reporting by following the Analysis Data Model (ADaM).
Ø Programming standard and custom data listings, summary tables, and graphs as specified in statistical analysis plan
Ø Extract the data from clinical database for data reporting purpose.
Ø Develop programming specifications by analyzing the protocol related documents. Meet the programming requirements for submissions as required
Ø Understand and plan work to delivery timelines including allowing time for internal QC, as appropriate
Ø Whenever required, collaborate with the statistician, data managers, and clinicians to resolve specifications and data related issues.
Ø Work with supervisor to balance conflicting priorities
Ø Understand timelines for and milestones affecting their work and alert supervisor and client representative to potential slippage
Ø Run routine QC programs, track the changes in programming and specifications, and document the QC results and resolutions.
Ø Carry out rework as requested by supervisor or client representative
Ø Follow escalation process and neither suppress nor over- escalate issues
Ø Contribute to close –out evaluations and any discussion
Ø Other duties as assigned.
Professional/Technical Skills & Experience
Ø Experience of extracting, manipulating, summarizing, analyzing and presenting data using SAS procedures
Ø Experience of SAS programming, Macro development, SQL and SAS/Connect procedures. Strong knowledge of reporting procedures like proc report, proc summary, and proc tabulate.
Ø Strong knowledge of SAS/GRAPH and Statistical procedures related to SAS/STAT
Ø Ability to validate SAS programs that produce derived-analysis datasets and data analyses
Ø Some experience in preparations for NDA filings. Thorough understanding of regulatory guidelines like Good Clinical Practices (GCP), ICH guidelines, 21 CFR part-11 compliance requirements.
Ø Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) expected
Ø Knowledge of CDISC® related data models like SDTM, and ADAM.
Ø Proficiency in Microsoft Office Applications
Ø Excellent verbal and written communication skills
Ø Detail oriented, ability to multitask with strong prioritization, planning and organization skills
Ø Excellent team player
Rajesh
248-809-5931
mailto: rajesh@ntc-us.com --
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