Loc : <st1:place w:st="on"><st1:City w:st="on">Indianapolis</st1:City>,<st1:State w:st="on">IN</st1:State></st1:place><o:p></o:p>

Employment : Permanent placement <o:p></o:p>

Salary : $60-65k(pa) <o:p></o:p>

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US CITIZENS or GREEN CARD HOLDER ONLY<o:p></o:p>

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Start ASAP<o:p></o:p>

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Clinical Statistical Programmer<o:p></o:p>

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Position Summary:<o:p></o:p>

Provides programming support, including documentation and validation, for producing integrated analyses, databases, listings, summaries, figures, and tables for Phase 3-4 clinical studies, along with integrated safety analyses, integrated efficacy analyses and publication requests.

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Principal Accountabilities:<o:p></o:p>

o        Review reporting requirements in consultation with Clinical Statisticians and Medical Writers<o:p></o:p>

o        Statistical reporting, creation of Tables Figures and Listings using SAS programming<o:p></o:p>

o        Validation of output results using Statistics Standard Operating Procedures <o:p></o:p>

o        Create Case Study Reports (CSR’s) using integrated databases for submission to FDA<o:p></o:p>

o        Create SAS reusable components to automate reporting <o:p></o:p>

o        Provide SAS Training to junior team members<o:p></o:p>

o       Identifies opportunities for process improvement and code optimization

EXPERIENCE:

Masters in Statistics or Engineering degree with 3-5 years of pharmaceutical experience in clinical programming and submission preparation. At least 3 years experience with SAS software system and good understanding of health authority regulations and guidelines regarding programming and computer system validation.

SKILLS: <o:p></o:p>

o        Clinical Data Analysis

o        Clinical Data Management

o        Documentation Skills

o        Excellent Communication Skills

 

S/W SKILLS:

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Base SAS, SAS STAT, SAS GRAPH, SQL.<o:p></o:p>

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ESSENTIAL SKILLS:<o:p></o:p>

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o        SAS<o:p></o:p>

o        Clinical Data Analysis<o:p></o:p>

o        Excellent communication skills  

 

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