Statistical Programmer 2, Medical Affairs/ RWE (FSP): Remote: These permanent, remote opportunities can be worked from anywhere in U.S. or Canada regions #LI-REMOTE

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  With sufficient experience assume the role of a Lead Statistical Programmer for CP studies only with support from senior programming staff.
  
  
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  Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
  
  
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  Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
  
  
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  Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated eCRFs and Reviewers Guides to support SDTMs and ADaMs
  
  
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  With support from senior programming staff, develop specifications for SDTMs and ADaM datasets
  
  
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  Review SAPs and TFL shells from a programming perspective for studies with support from senior programming staff
  
  
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  Respond to QA and client audits with support from senior programming staff
  
  
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  Demonstrates good understanding of statistical concepts and methodologies.
  
  
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  Takes a lead role in introducing new/novel statistical methodological approaches into innovative study designs and/or analysis plans which improve the efficiency and sensitivity of study results.
  
  
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  Provides sufficient details to allow programming implementation. Ensures that all the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately
  
  
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  In collaboration with GMA, Clinical Statistics, Data Sciences, Statistical Programming and other stakeholders to assess and evaluate existing databases and real world evidence for evidence evaluation and generation to deliver useful, customer-centric evidence and insights to drive decisions
  
  
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  Reviews identified or anticipated technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research.
  
  
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  Works collaboratively with members of multi-function teams to complete project deliverables per agreed timelines.
  
  
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  Keeps management informed on important scientific/statistical issues that may arise, in a timely manner.
  
  
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  Provides responses to routine and non-routine questions from clients, and independently pursues analyses suggested by the data.
  
  
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  Ensure accuracy and internal consistency of reports and publications, including analyses, tables, listings and figures. Get familiar with the database.
  
  
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  Recognize and report on flaws in scientific logic and statistical interpretation.
  
  
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  Ensure consistency in presentation, inference and adherence to accepted report guidelines and publication practices. In particular, for statistical methods sections of reports, ensure internal consistency for routine situations and alignment with analyses as conducted.
  
  

Minimum Required:

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  Bachelor’s degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects.
  
  
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  Experience and/or education plus relevant work experience, equating to a Bachelor's degree
  
  

Minimum Required:

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  Typically 1 - 2 years of SAS® programming experience in the CRO or Pharmaceutical industry, or an equivalent combination of education and Experience to successfully perform the key responsibilities of the job
  
  
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  Knowledge of CDISC requirements
  
  

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